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Full text of "Environmental Protection Agency and the regulation of pesticides: staff report"

[COMMITTEE PRINT] 



94th Congress \ 



2d Session 



SENATE 



THE ENVIRONMENTAL PROTECTION AGENCY 
AND THE REGULATION OF PESTICIDES 



STAFF REPORT 

TO THE 

SUBCOMMITTEE ON ADMINISTRATIVE PRACTICE 
AND PROCEDURE 

OF THE 

COMMITTEE ON" THE JUDICIARY 

OF THE 

UNITED STATES SENATE 

DECEMBER 1976 



j////""**^ 





Printed for the use of the Committee on the Judiciary 



79-661 



U.S. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1976 



For sale by the Superintendent of Documents, U.S. Government Printing Office 

Washington, D.C. 20402 - Price 70 cents 

Stock Number 052-O7-03SG7-5 



COMMITTEE ON THE JUDICIARY 

JAMES 0. EASTLAND, Mississippi, Chairman 

JOHN L. McCLELLAN, Arkansas ROMAN L. HRUSKA, Nebraska 

PHILIP A. HART, Michigan HIRAM L. FONG, Hawaii 

EDWARD M. KENNEDY, Massachusetts HUGH SCOTT, Pennsylvania 

BIRCH BAYH, Indiana STROM THURMOND, South Carolina 

QUENTIN N. BURDICK, North Dakota CHARLES McC. MATHIAS. Jr., Marj land 

ROBERT C. BYRD, West Virginia WILLIAM L. SCOTT, Virginia 
JOHN V. TUNNEY, California 
JAMES ABOUREZK, South Dakota 



Subcommittee on Administrative Practice and Procedure 

EDWARD M. KENNEDY, Massachusetts, Chairman 
PHILIP A. HART, Michigan STROM THURMOND, South Carolina 

BIRCH BAYH, Indiana CHARLES McC. MATHIAS. Jr., Maryland 

QUENTIN N. BURDICK, North Dakota HUGH SCOTT, Pennsylvania 

JOHN V. TUNNEY, California 

Thomas M. Susmax, Chief Counsel 
Philip J. Bakes, Jr., Assistant Chief Counsel 
Walter J. Sheridan, Chief Investigator 
James P. Michie, Investigator 

in) 



Table of Contents 



.Page 

Introduction by Senator Kennedy 1 

I. Overview 3 

II. Poor Planning and Management 11 

III. Lengthy Delays in Correcting Serious Program Deficiencies 23 

IV. Lepthophos: A Case History Illustrating the Severe Inadequacies 

and Deficiencies in EPA's Tolerance-Setting Program 35 

V. Misleading Statements by EPA 43 

VI. Recommendations 49 



Documents cited in this report and other documents relating to the 
subcommittee staff's inquiry into regulation of pesticides by the EPA 
are contained in a separately bound appendix. 



[Note: This report was prepared by the majority staff of the subcommittee 
and has been neither reviewed nor approved by the Members of the 
subcommittee.] 

(Hi) 



Digitized by the Internet Archive 
in 2013 



http://archive.org/details/entalproOOunit 



THE ENVIRONMENTAL PROTECTION AGENCY 
AND THE REGULATION OF PESTICIDES 

INTRODUCTION 

Pesticides have played and continue to play an important role in 
increasing agricultural production in America, and around the world. 
Pesticides have proved valuable in the past, and may be needed for 
some years to come until safer and more effective methods of pest 
control are developed. But pesticides are powerful poisons also. A 
number of pesticides have the potential for causing such tragic effects 
on man and the environment as cancer, birth defects, interference with 
biological reproduction, and genetic mutations. 

The subcommittee staff's report on pesticide regulation leads me to 
conclude that the Environmental Protection Agency has largely 
failed in its responsibility to assure the safe use of pesticides as man- 
dated by the Congress. As a consequence, EPA has failed the consumer 
and the farmer, as well as the pesticide industry. 

I find it incredible that a regulatory agency charged with safe- 
guarding the public health and the environment would be so sluggish 
to recognize and react to so many warnings over the past 5 years. The 
EPA was warned and certainly should have known that testing data, 
submitted by industry as long as 25 years ago, should not be accepted 
at face value in the reregistration of thousands of pesticide products 
presently being used on our farms and in our homes. But EPA by and 
large ignored these warnings. 

Even more alarming is that apparently EPA made a conscious policy 
decision sometime in 1973 or 1974 not to evaluate the safety testing 
data submitted by pesticide manufacturers. The record behind this 
decision is not entirety clear. What is clear, however, is that EPA had 
no sound basis upon which to assume that data 15, 20, or 25 years old 
was generally good and reliable. EPA has yet to produce one document 
which discusses even vaguely the rationale for its decision not to 
evaluate data or possible alternatives to that decision. In my view, 
EPA's decision in the 1970's not to evaluate safety testing data sub- 
mitted in the 1950's and 1960's was irresponsible in light of the dra- 
matic improvements science has made in safety testing methodology 
and interpretation of testing data. 

I fully appreciate the constraints under which EPA was operating 
in attempting to perform the pesticide reregistration task. The agency 
was faced with a Congressional deadline of October 1976 (later 
extended to October 1977) to complete it. Determining whether to 
reregister 50,000 pesticide products currently on the market is an 
enormous undertaking. EPA was unable to obtain sufficient resources 
with which to accomplish the task. These factors have played a part in 
making pesticide regulation a failure. But, EPA must shoulder the 
major share of the blame. Not until very recently did EPA inform 
the Congress and the public that these constraints forced the agency 
into the untenable and dangerous decision not to evaluate and validate 
much of the safety testing data in the reregistration process. In fact, 
as the staff report demonstrates, EPA's presentations to Congress 
have given a very misleading picture of pesticide regulation. 

(l) 



I am heartened by the valuable contributions made during the 
subcommittee's lengthy inquiry by scores of EPA employees — clerks, 
secretaries, scientists, supervisory personnel, and attorneys — all of 
^vhom showed their dedication to the public health and their commit- 
ment to Federal regulation of pesticides. I also appreciate the full 
cooperation and assistance extended to the subcommittee staff by 
Administrator Russell E. Train and officials within the Office of 
Pesticide Programs. 

It is most encouraging to see that EPA has already taken steps to 
improve the regulation of pesticides, including finalization of a program 
to validate data supporting ^registration, organization of EPA's 
data files, initiation of a program with the Food and Drug Administra- 
tion to audit safety testing results, formation of a Cancer Assessment 
Group, and initiation of a program to attract more scientists so as 
to improve the agency's expertise in the various scientific disciplines. 

It is my hope that this report, in pointing out the many problems 
and deficiencies in EPA's pesticide programs, will stimulate within 
the executive branch, the Congress, the public sector, and the pesti- 
cide industry a renewed commitment to effective and fair regulation 
of pesticides in the future. 

Edward M. Kennedy, Chairman, 
Subcommittee on Administrative Practice and Procedure. 



I. OVERVIEW 

The Environmental Protection Agency was established as an inde- 
pendent agency on December 2, 1970. 1 EPA was created to provide a 
central focal point for coordinated and effective governmental action 
on behalf of the environment. It is responsible, among other things, 
for regulating the use of pesticides through "the administration of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947 2 
and sections 408 3 and 409 4 of the Federal Food, Drug, and Cosmetic 
Act (FFDCA). 

The Congress passed these two laws to protect the public health 
and the environment. While pesticides are meant to control insects, 
rodents, and other pests and thus increase agricultural production, 
the uncontrolled use of these poisonous substances can kill and 
cripple humans, farm animals, fish, birds, and other wildlife, can in- 
filtrate the food chain, and are potentially hazardous to entire eco- 
logical systems. Scientific research undertaken by the pesticide in- 
dustry, as well as by Government agencies, demonstrates that possibly 
a substantial number of pesticides have the potential for causing in 
humans cancer, birth defects, damage to the nervous system, genetic 
mutations, interference with biological reproduction, and other 
harmful effects. 

Proper regulation of pesticides is today more necessary and more 
difficult than ever before. The use of these poisons has increased 
dramatically since the midsixties, and the business of producing and 
marketing them has mushroomed as well. The U.S. market for pesti- 
cides in 1974 was $1.9 billion and is expected to climb to $3.3 billion by 
1984. 5 Production of pesticides inthe U.S. almost doubled in a 9-year 
period, from 877 million pounds in 1965 to 1.4 billion pounds in 1974. 6 
EPA states: 

55 percent [of active pesticide ingredients are consumed] 
by the agricultural sector; 30 percent by industrial, institutional 
and Government users; and 15 percent by home and garden 
users. . . [and] the use of chemical pesticides is expected to 
continue to increase during the next 5 years. 7 

In light of the pervasiveness of pesticide use, the potential dangers 
inherent in that use, and thus the importance of pesticide regulation, 
the Subcommittee on Administrative Practice and Procedure began 
studying EPA's administration of the FIFRA and sections 408 and 
409' of the FFDCA in early January 1976. 

1 Reorganization lanP No. 3 of 1970. 

2 61 Stat. 163 as amended. 

3 Pub. L. 83-518, July 22, 19.54, chapter 559, 83d Cong., 2d sess., 21 U.S.C. 321. 
« Pub. L. 85-929, Sept. 6, 1958, 21 U.S.C. 321. 

5 Draft, "Strategy of the Environmental Protection Agency for Controlling the Supply and Lse of Pesticides, 
1976-81," EPA, July 1976. 

« "The Pesticide Review 1975," USDA, Agricultural Stabilization and Conservation Service, Washing- 
ton, July 197fi 

7 Note 5, supra. 

(3) 



An intensive inquiry, 8 which is still continuing today, has led to 
the unfortunate conclusion that pesticides regulation in the United 
States is fundamentally deficient. Pesticides regulation has failed to 
include many obvious, necessary, and prudent steps to better protect 
public health and the environment. Moreover, the severe inadequacies 
of pesticide regulation are not attributable in any significant way to 
deficient legislation. Rather the principal cause lies with EPA's poor 
administration of the program, including its failure to recognize and 
correct serious program deficiencies as they arose. In an almost classic 
example of poor governmental regulation, EPA's pesticide program 
has struck an incorrect and dangerous balance between the sometimes 
conflicting demands of limited resources, bureaucratic efficiency and 
public health. EPA for 6 years has paid too little attention to 
warnings of Government investigators, Congressional reviews, and 
even some of its own officials. The result is that several years of regu- 
latory effort will have to be completely reexamined, substantially 
redone, and fundamentally redirected if the Congress and the public 
are to have a reasonable basis to conclude that today's pesticides do 
not pose a significant risk to human health and the environment. The 
pesticide industry and the Nation's farmers can no longer confidently 
rely on EPA's past reviews of pesticide safety testing data, for much 
of that work must simply be redone. Moreover, a substantial amount of 
time and money has been wasted, and the speedy approval of new 
pesticides that are both safe and effective is jeopardized because of 
EPA's need to devote resources to substantially redoing its pesticide 
reregistration program. 

The regulation of pesticides has been fraught with problems since 
its beginning in 1947. Prior to the creation of EPA, FIFRA had been 
administered bv the Department of Agriculture, and FFDCA, bv the 
Food and Drug Administration in HEW. Under FIFRA, USDA was 
required to register all pesticide products involved in interstate 
commerce. However, USDA could not register a pesticide if it left 
a residue in or on a raw agricultural product unless FDA was able to 
set a "safe" tolerance level, as required by the FFDCA. FDA could re- 
fuse to grant a tolerance if that Agency determined that any residue 
was dangerous to human health and thus FDA could effectively pro- 
hibit USDA from registering the pesticide use. 

In the late sixties, the regulation of pesticides came under heavy 
criticism. Tv.<> reports by the General Accounting Office charged that 
QSDA J n pstration procedures were inefficient, failed to place ade- 
quate emphasis on pesticide safety, and too often ignored the recom- 
mendations of FDA. 9 

The fragmentation of authority to regulate pesticides between 

>A and FDA was detrimental to the program. Moreover, a conflict. 

between the fund a menial missions of the two agencies also cont ributed 

heavily to the failure of pesticide regulation. Traditionally, DSDA's 

ion has been to promote Lncreasea food production and, therefore, 



* Since this stud: ubcommittei I testimony from 14 witm 

'parate 
Bws were conducted. EPA i psubcommltl KJOdocu- 

one "f which lias been reviewed bj the ^uir. The stafl riewed the • 

.1 the subject «if pe tlclde regulation and baa studied the reports of the oao on 
this program. 

mlatory Enforcement Pri det," OAO Report to tl 

jept. 10, 1968. B i Veed to RetolPi Que$tiont '■ Certain Regiatei •■ ' <■ I 



USDA heavily promoted the use of pesticides to accomplish that mis- 
sion. Long-term health concerns were often subordinate to USDA's 
primary goal. FDA, on the other hand, was charged with safeguarding 
the public health. Assigning all pesticide regulation to one agency 
helped alleviate bureaucratic overlap and administrative inefficiency; 
but Government reorganization did not cure the basic conflict, in as 
much as many of the personnel and much of the philosophy from 
USDA were simply transferred to the EPA pesticide program in 1970. 

In 1972, EPA's pesticide regulatory task was expanded greatly 
with the enactment of the Federal Environmental Pesticide Control 
Act (FEPCA) 10 which amended FIFE A. In addition to requiring the 
processing of new pesticide registration applications and pesticide 
residue tolerance petitions, FEPCA requires that all pesticide products 
previously registered over the past 30 years — including some 35,000 
federally by USDA and by EPA since 1970, and 15,000 by states— be 
reviewed and subject to a reregistration process, and classified for 
either general or restricted use, or both. This task was directed by 
Congress to be accomplished by October 21, 1976. n The intent of the 
Congress in enacting FEPCA was to subject those pesticides approved 
under earlier, less stringent safety standards to application of much 
improved modern standards. Under FEPCA, Congress placed on 
EPA the responsibility to determine whether any of these pesticides 
"will perform [their] intended function without unreasonable adverse 
effects" 12 on human health and on the environment. If, after an 
examination of the risks and benefits, the Administrator of EPA 
determines that the pesticide causes "unreasonable adverse effects," 
he may restrict, suspend, or cancel the use of the pesticide. 

Following the enactment of FEPCA, pesticide companies were 
required to supply for reregistration: (1) animal testing data to show 
whether their products had the potential for causing birth defects, 
tumors, interference with reproduction capability or other harmful 
chronic effects, and (2) data on the exposure to pesticides which might 
affect fish and mammals and birds. 

The importance of EPA's determining whether the previously 
registered 50,000 pesticide products should be reregistered for con- 
tinued use cannot be overemphasized. Over the past 22 years, more 
than 4,000 tolerances have been granted, allowing residues of many 
pesticides to remain in or on such foods as vegetables, meat, milk, and 
grains. These substances are then ingested by people and many of 
them degrade very slowly. Years later traces are found in human 
tissue. The long-term effects of many of these substances are often 
quite harmful and in many cases unknown. Recently, for example, 
reports have shown that the pesticides Mirex and Kepone are showing 
up in human mothers milk. Both have been identified as carcinogens 
and, according to EPA, "over the last decade, pesticide monitoring 
in humans has confirmed the widespread presence of residues. ... In 
1973, for instance, adipose (fatty) tissue from 99 percent of the humans 
sampled contained Dieldrin. . . .", 13 a known carcinogen. The use of 
Dieidrin was cancelled by EPA in 1975, but a number of other pesti- 
cides related in chemical structure remain on the market. 



<■■> Pub. L. 92-516, Oct. 21. 1972, 7 U.S.C. 13.5. 
•' Pub. L. 92-516, Oct. 21, 1972, 7 U.S.C. 135. 
'2 Pub. L. 94-140, Nov. 23, 1975, 7 U.S.C. 136. 
13 Note 5, supra. 

79-661-76 2 



6 

EPA was quite slow, however, in getting reregistration underway; 
slow planning and long: delays in drafting regulations and guidelines 
mandated by the FEPCA were responsible for keeping actual re- 
registration from becoming operational. In fact, the formal prepa- 
ration phase of reregistration, which involved the drafting of guidance 
packages for pesticide companies who wished to reregister their 
products, did not begin until the fall of 1975, some 3 years after 
enactment of the FEPCA. Even so, with only a year remaining until 
the original Congressional deadline of October 1976, EPA did not 
request an extension from Congress. Nevertheless, on November 28, 
1975, the Congress decided to extend the deadline until October 21, 
1977. 14 And, since the fall of 1975 when the program became oper- 
ational, EPA has been constrained to halt and redirect it on two 
occasions. 

As part of the reregistration program, EPA did establish in late 
1975 the Office of Special Pesticide Reviews (OSPR), which was 
charged with assuring that a thorough evaluation would be performed 
on those pesticide chemicals suspected of having the potential to 
cause adverse effects on human health and the environment. But, 
like EPA's effort to reregister those pesticide chemicals which were 
not in the "suspect" category, EPA has had serious difficulties in 
getting the OSPR program underway and in making it effective. 

As shown in the brief summary which follows, the reregistration 
program has to this day never been fully implemented and is unlikely 
to be completed in time for the statutory deadline of October 1977. In 
fact, it was only recently, in response to the subcommittee's inquiry, 
that EPA now estimates it will take approximately 3 years to complete 
reregistration. 

On January 13, 1976, following months of work in preparing 45 
guidance packages, the reregistration program was virtually halted 
for more than a month. This was clone after EPA discovered that 
reviews of existing pesticide safety testing data in its files had been 
superficial and the program mismanaged. Corrective action was 
clearly called for. 

During that same week of January 12, 1976, the Office of Pesticide 
Program- had assigned four EPA scientists to review a sampling of 
existing safety testing reports from animal feeding studies which 
pesticide companies had used to justify the initial registrations of 
their products, as well as tolerances for residues of their products 
in and on foods and feeds. This was the very same type of data that 
was required to be reviewed and validated in reregistration. Although 
their reviews were performed hastily, the scientists discovered faulty 
and incomplete data. This limited review of data was done in prepara- 
tion for testimony by Mr. John K. Quarles, Jr., Deputy Administrator 
of EPA, who was scheduled to appear, along with representatives 
of the Food and Drug Administration and the National Cancer 
[nstitute, before a joint hearing of the Subcommittee on Health and 
this subcommittee, which were investigating suspected large-scale 
problems with the integrity of animal feeding studies furnished by 
private companies seeking governmental approval of their product-. 

'« I'ub. L. W-140. Nm 136. 



On January 20, 1976, in hearings before the subcommittees 
Mr. Quarles testifed : 

There are indications that serious problems may exist . . . 

a recent preliminary review of several toxicity studies submitted 

to EPA have alerted us to the possibilit}?- of serious difficiencies 

in the conduct of pesticide testing. 15 

Following the January 20 hearings, one of the scientists, a 

pathologist, was assigned to do more thorough reviews of the data. 

He reported to his superiors on March 11, 1976, that of the 24 reports 

on safety testing studies he had reviewed, only one was acceptable. 

Meanwhile, at about the same time (in mid-March) the reregistia- 

tion program was resumed. And, as the Congress had directed in 

FEPCA, the program supposedly included reviews of testing studies 

to determine whether the data were adequate to support a finding 

that each pesticide was safe. 

On April 9, 1976, in hearings before the Subcommittees on Health 
and Administrative Practice and Procedure, Mr. Russell E. Train, 
Administrator of EPA, testified: 

[The pathologist's findings] . . . obviously indicated that 
EPA must take steps to review more thoroughly the adequacy 
of past testing and ensure that future laboratory testing is 
properly performed. . . . EPA will initiate an auditing pro- 
gram in which laboratory records of toxicity test reports will be 
examined to determine whether they accurately reflect the re- 
ported test procedure and results. 16 
Pvef erring to reregistration, Mr. Train further testified : 

Pursuant to the 1972 amendments to the FIFRA, the EPA 

is directed to undertake a reappraisal of pesticide products 

approved under the earlier FIFRA to determine if they meet a 

new statutory test that they will not have the ' 'unreasonable 

adverse effects" to man and the environment. . . . On February 

17 we published a list of pesticides categorized according to the 

acceptability of their supporting data in view of the new 

regulations. 17 

Later, at those same hearings on Apiil 9, Mr. Jeffery Howard, the 

former EPA Associate Assistant General Counsel for Pesticides who 

had recently resigned stated, "EPA has not carefully scrutinized the 

safety testing data submitted to it [by the pesticide companies].' ' 

Ms. Carter Schuth, a scientist in EPA's Office of Toxic Substances, 

referred to reregistration in her testimon}" as a "a production line." 

When asked by Chairman Kennedy, "Do you think we are not really 

getting the desired goal of comprehensive evaluation [of the data]". 

Ms. Schuth responded, "Yes, sir, I think that is a very serious 

danger." 18 

Following the April 9 hearings, the subcommittee's inquiry con- 
tinued, and so did the reregistration program. EPA was sending out 

16 Statement of John R. Quarles, Jr., Deputy Administrator, Environmental Protection Agency, before 
joint hearings by the Subcommittee on Health and the Subcommittee on Administrative Practice and 
Procedure, Jan. 20, 1976. 

18 Statement of Russell E. Train, Administrator, Environmental Protection Agency, before joint hearing, 
by the Subcommittee on Health and the Subcommittee on Administrative Practice and Procedure, Apr. 9 
1976. 

> 7 Ibid. 

18 Testimony of Ms. Carter Schuth, scientist, Office of Toxic Substances, Environmental Protection 
Agency, before joint hearings by the. Subcommittee on Health and the Subcommittee on Administrative 
Practice and Procedure, Apr. 9, 1976. 



8 

guidance packages each week to pesticide companies. The guidance 
packages indicated to companies EPA's judgment concerning the 
adequacy of data previously submitted by the companies. 

On July 1, 1976, Chairman Kennedy wrote a letter 19 to Mr. Train 
requesting from the EPA Administrator detailed information on the 
depth of data review fur reregistration and tolerance-setting. Chair- 
man Kennedy, among other things, requested information on the 
extent to which EPA had reviewed safety testing data relating to 12 
specific pesticide compounds for which reregistration guidance pack- 
ages had already been prepared and mailed to the respective 
manufacturers. 

The reregistration process continued until August 9, 1976, when the 
Office of Pesticide Programs halted the process for the second time in 
8 months because the review of data was still superficial. As it turned 
out, the reregistration program's "review" of the data had consisted 
of little more than merely looking for the presence of data. It still 
did not approach fulfilling the Congressional intent behind the 1972 
FEPCA legislation — namely, to ensure that each of the pesticides 
"will perform its intended function without unreasonable adverse 
effects" on human health and the environment. 

Finally, in a letter dated August 10, 1976, Mr. Train responded to 
Chairman Kennedy's letter of July 1, 1976: 

EPA currently is rethinking the depth of analysis associated 
with its strategy for reregistering pesticides. In particular, we 
are taking a second look at the extent to which information in 
our files, particularly information pertinent to an assessment of 
potential human health hazards of pesticides, should be re- 
examined before reregistrations are issued. We originally assumed 
that toxicological data in our files were derived from testing 
that generally was scientifically sound, that test procedures and 
results had been fully and accurately reported, that test reports 
generally had been reviewed in accordance with scientific standards 
that are still appropriate, and that problems identified by prior 
reviewers had been resolved. In light of recent developments, 
these assumptions are now questionable. 20 
Since August 9, 1976, when the reregistration program was halted, 
the Office of Pesticide Programs has been working on a plan to fulfill 
the mandate of the Congress in providing for a thorough review of 
existing safety testing data on all of the 50.000 pesticide products 
presently manufactured and marketed in the U.S. 

While the reregistration program is of paramount importance in 
EPA's mi»ion to protect the public health and the environment 
from potential hazards of pesticide use, of perhaps equal importance 
is the review of the more than 4,i)()() existing tolerances for maximum 
pesticide residues in or on foods and feeds granted over the past 22 
years, as well a^ t review of the tolerance-setting procedure. For if 
much of the data to be reviewed for reregistration purposes is Faulty 

or incomplete, many of the pesticide residue tolerances now in effect 
may have bo be revoked, or at least modified. 



i '.!. Kennedy, Chairman, Subcommittee on Adminlstra- 
. ire, to .Mr. Russell k. Train, Administrator, Environmental Protection A.geno] . 
-° Letl d .'• I lug. 20, 1976, from Mr. Russell E. Train, Administrator, Environmental Protection 
I Iward m. Kenned in, Subcommittee on Eealtb and Subcommittee on Ad- 

lure. 



Ill a report to the Congress highly critical of EPA's pesticide 
programs, the General Accounting Office recommended that EPA 
"periodically review all tolerances and revise as necessary." 21 EPA, in a 
letter dated September 17, 1975, responded that it was "very much 
concerned about tolerance-setting problems," 22 and promised to 
"turn more of [its] attention to review of the tolerance regulations and 
procedures, to reassessment of tolerances already regulated, and to a 
comprehensive evaluation of the whole scientific basis for tolerance 
setting." 23 

However, after more than a year, the Office of Pesticide Programs 
still is in the process of organizing and putting in writing its existing 
procedures for tolerance-setting. And it was only recently that decisions 
were made to begin an "evaluation of the whole scientific basis for 
tolerance-setting." 24 

In succeeding sections of this report, the staff of the Subcommittee 
on Administrative Practice and Procedure documents what it believes 
to be the major problems which have led to the crisis in which 
pesticide regulation finds itself today. They are: (1) Poor planning 
and management; (2) lengthy delays in correcting serious program 
deficiencies, and (3) misleading statements to the Congress, GAO, and 
the public. 

21 "Federal Pesticide Registration Program: Is It Protecting the Public and the Environment Adequately 
From Pesticide Hazards?", report to the Congress by the Comptroller General of the U.S., Dec. 4, 1975. 
« Ibid. 
»» Ibid. 
* Ibid. 



II. POOR PLANNING AND MANAGEMENT 

Organizational delay 

The Office of Pesticide Programs (OPP) basically consists of five 
suborganizations: (1) Registration Division; (2) Criteria and Evalua- 
tion Division; (3) Technical Services Division; (4) Operations Division; 
and (5) Office of Special Pesticide Reviews. 25 

From the beginning of EPA, the Registration Division has played 
the primary role in pesticide regulation within the Office of Pesticide 
Programs. Prior to enactment of FEPCA 26 in 1972, the Registration 
Division's task was to approve or disapprove applications for new 
pesticide registrations, and pesticide residue tolerance petitions. 

Following the enactment of FEPCA, OPP was reorganized, with 
the newly created Divisions of Criteria and Evaluation, Technical 
Services, and Operations serving largely as support to the Registration 
Division. 

The Office of Special Pesticide Reviews (OSPR) was not created 
until December 1975. OSPR's function is to perform indepth risk- 
benefit analyses on those pesticides suspected of causing "unreasonable 
adverse effects. " These analyses are used by the Administrator in 
determining basically to what extent the pesticide should remain in 
use, or whether it should be removed from the market entirely, as 
provided for in FEPCA. 27 

With the enactment of FEPCA on October 21, 1972, the Congress 
required EPA to reregister and classif}- for general use or restricted 
use, or both, by October 21, 1976, the 35,000 pesticide products pre- 
viously registered for use by USD A and EPA and 15,000 pesticide 
products previously registered by states. FEPCA further directed 
EPA to promulgate within 2 years regulations which would fulfill the 
new provisions of the Act affecting reregistration, as well as new regis- 
trations of pesticide products. 



w The basic functions of the five suborganizations are as follows: (1) the Registration Division is responsi 
ble for establishing pesticide residue tolerances in and on foods and feeds, and for the registration and re- 
registration of pesticides and their use to assure human safety and protection of environmental quality. 
(2) The Criteria and Evaluation Division is responsible for establishing standards and criteria for tolerance 
setting, and for environmental, human safety, and efficacy standards applicable to product registration, and 
for research needs of OPP. (3) The Technical Services Division is charged with providing technical data and 
information support to other divisions in OPP, as well as to States and other agencies, and with monitoring 
pesticide residue levels in the environment and the effects on humans exposed to pesticides. (4) The Opera- 
tions Division is responsible for coordinating O PP's regional activities, for implementing the States' certifica- 
tion programs for pesticide and investigating pesticide accidents. And (5) the Office of Special Pesticide Re- 
views is responsible for assuring that chemicals identified as Rebuttable Presumption Against Registration 
(RPAR) cases are properly evaluated and processed. 

M Note 10, supra. 

27 The Federal Environmental Pesticide Control Act of 1972 provides that: 

If it appears to the Administrator that a pesticide or its labeling or other material required to be sub- 
mitted does not comply with the provisions of this Act or, when used in accordance with widespread 
and commonly recognized practice, generally causes unreasonable adverse effects on the environment, 
the Administrator may issue a notice of his intent either — 

(1) to cancel its registration or to change its classification together with the reasons (including the 
factual basis) for his action, or 

(2) to hold a hearing to determine whether or not its registration should be canceled or its classi- 
fication changed."; and that 

"If the Administrator determines that action is necessary to prevent an imminent hazard during 
the time required for cancellation or change In classiiication proceedings, he may, by order, suspend 
the registration of the pesticide immediately. 

(ID 



12 

The planning and management efforts to draft the regulations 
necessary for implementation of the reregistration program were 
extremely poor from the beginning. A task force was created in Decem- 
ber 1972, immediately following enactment of FEPCA, to draft the 
regulations. However, there was "difficulty in coordination" between 
the task force and those OPP branch chiefs who were to provide 
scientific input. 28 In 1973, the drafting of the regulations was turned 
over to the branch chiefs. And, from the branch chiefs, the task was 
transferred to another task force in April or May 1974. 29 

The regulations themselves were not finalized until August 4, 
1975, some 10 months after the Congressional deadline of October 21, 

1974. And the reregistration program itself did not begin until October 

1975, leaving only 1 year to perform the entire task. However, on 
November 28, 1975, the Congress extended the deadline to October 
21, 1977. 30 

Decision to take shortcuts 

On October 19, 1976, Edwin L. Johnson, presently the Deputy 
Assistant Administrator for OPP, stated that soon after the enact- 
ment of FEPCA, the drafting of the regulations was begun, but 
"floundered" for 1% y ears. Johnson said that Henry J. Korp, his 
predecessor, and immediate superior at that time, directed him to 
"speed up the regulations." Mr. Johnson further stated that this led 
to him calling a meeting of OPP managers at Easton, Md., in April 
1974. 31 

According to Mr. Johnson, the "Easton meeting" was used to 
"conceptualize" the regulations and the reregistration process. Mr. 
Johnson indicated that because of known constraints, it was decided 
at the "Easton meeting" that instead of reviewing each of the thou- 
sands of pesticide products for reregistration, products of a similar 
chemical structure would be combined into "batches." The 50,000 
pesticide products presently on the market are made up of at least 
one or a combination of two or more of some 1,400 active pesticide 
ingredients. 

John B. Ritch, Director of OPP's Registration Division, attended 
the "Easton meeting." Mr. Ritch, when asked about resource con- 
straints on reregistration which were known at the time of the "Easton 
meeting," stated that, as early as 1973 the Registration Division had 
requested an additional 100 personnel in order to complete the 
reregistration process but, according to Mr. Ritch, the request was 
(ii approved by the Office of Management and Budget. Mr. Ritch 
further Btated : 

In the spring of 1974, at the budget review for fiscal year 
1975, it was decided that my Division would receive only 15 or 
20 additional personnel. At that point, we asked ourselves, how 
can you do a thorough job on reregistration with bo few addi- 
tional people, and still meet the Congressional deadline [of 
October 1976 for completing the task]? And that's when we 
began thinking about shortcuts. 32 



tafl Interview of Edwin L.Johnson, Deputy Assistant Administrator, Office of Pe 
■ i vi mil in ci i in i Protection Agency, Oct. 19, 1976 [hereafter "Johnson Interview"]. 
••• Note 28, supra, Johnson Interview. 

" Not<- 14, supra. 

"' Mote 28, supra, Johnson interview. 

m Subcommittee stuff Interview of John n. Ritch, Director, Registration Division, Office of Pesticide 
i Environmental Protection Agency, Oct. 16, 1976. 



13 

Mr. Johnson briefed John R. Quarles, Deputy Administrator of 
EPA, on May 1, 1974, on the "Easton meeting" plan for completing 
reregistration by the October 1976 deadline, in spite of resource 
constraints. 33 A flow chart, which Johnson said was used in the 
Quarles briefing, asks the questions: 

Does [the pesticide] product have potential long-term [harmful] 

effect? [If the answer is yes] Are sufficient data available to 

reach [a] [re]registration decision? [If the answer is yes] On [the] 

basis of intensive C/B [cost to health and environment vs. 

benefit] review, should [the pesticide] product be registered? 34 

The flow chart indicates that OPP had intended to do intensive 

review of pesticide safety testing data on those pesticides requiring 

"intensive C/B analysis." But, the chart also indicated that only 

"5 percent" or 2,250 of the 45,000 pesticides, would exhibit "potential 

unreasonable adverse long-term effects and, thus, require "intensive 

C/B analysis." The chart further stated that "approximately 75 

percent of [re]registration actions require no C/B analysis, greatly 

facilitating [the] workload," and that for 20 percent of the pesticides, 

only "moderate C/B analysis [would be] required [for pesticides] with 

potential unreasonable adverse acute effects." When asked how 

these figures could be arrived at before anyone had even begun 

systematically to examine EPA's voluminous pesticide safety testing 

files, Mr. Johnson said, "These were guesstimates based on the 

knowledge and experience of our scientists." Mr. Johnson further 

stated that Mr. Quarles agreed with the plan. 35 

Shortly after the Quarles briefing, EPA published "Strategy for 
Controlling the Adverse Effects of Pesticides," dated May 1974. 
The document, signed by Mr. Quarles for Russell E. Train, Ad- 
ministrator of EPA, stated generally how the Agency would perform 
the reregistration: 

All pesticides that have neither exhibited nor are suspected 
of causing significant adverse impacts will be reregistered upon 
manufacturer application and without requiring further testing 
data. . . . [F]ull testing data, including results of animal 
toxicological studies, will be required to support reregistration 
petitions for those pesticides suspect because of ingredients or 
use history. This group of chemicals may be subject to a complete 

review, comparing their benefits and costs, before reregistration 

Emphasis will be placed upon persistent and bioaccumulative 
pesticides and those pesticides which potentially present long- 
term health risks or special dangers to household users. 36 
On October 19, 1976, Edwin L. Johnson, Deputy Assistant Admin- 
istrator for OPP, told subcommittee staff, "During the preparation of 
the 1974 strategy document, we asked several of our scientists about 
the [existing safety testing] data in the files, and they told us it was 
generally good." 3? 

33 Note 28, supra, Johnson interview. 

34 Memorandum, "Notes on Quarles Briefing," with appended charts, May 1, 1974. 
85 Note 28, supra, Johnson interview. 

34 "Strategy of the Environmental Protection Agency for Controlling the Adverse Effects of Pesticides," Office 
of Pesticide Programs, Office of Water and Hazardous Materials, Environmental Protection Agency, May 
1974. 

37 Note 28, supra, Johnson interview. 



79-661—76 3 



14 

The next major effort by OPP in planning and organizing for the 
reregistration program did not begin until February 1975, 9 months 
after the "Easton meeting.' 5 The "Grandpierre Task Force," 3S as it 
has come to be known, met almost daily for about 2 weeks, beginning 
on February 20, 1975. 

Effective planning by the group was constrained by the premise 
that reregistration must be completed by October 21, 1976, as had 
been mandated by the 1972 amendments to FIFE A. 

one of the participants of the "Grandpierre Task Force" stated, 
"The mandate of the task force was to meet the deadline of October 
1976 [for completing reregistration] . . . We were told to do it, 
regardless." 39 Another participant explained that: 

[When the task force met,] [t]he basic decisions on how we 
would approach reregistration had essentially been made at the 
'Easton meeting' [9 months earlier] — decisions to shortcut re- 
registration. 40 
The shortcuts included such things as foregoing a product-by- 
product review and relying on the review of batches of products 
instead; 41 deciding not to review thoroughly pesticide labeling which 
was to give directions for proper use; 42 simply assuming, without 
really analyzing whether, the pesticides under review were effective 
in controlling pests. 43 

Decision not to validate data submitted by manufacturers 

On the precise question of reviewing or validating pesticide safety 
testing data, the recollections of various participants are sometimes 
vague and conflicting. For example, while one participant contends 
that they assumed validation would be done, 44 another claims he told 
the "Grandpierre" task force that it could not be done within the con- 
fines of the original Congressional deadline, 45 and still another indicated 
that the task force decided that reregistration would merely identify 
the presence or absence of data. 40 Apart from the accuracy of the 
participants' recollections, the simple and clear fact is that the actual 
bask of reviewing and validating safety testing data was hardly 
performed at all or performed superficially at best. And, even though 
there were documents 47 prepared following the decisions of the^task 



m Members of the Task Forco included: E. L. J. Grandpierre, Chairman of the Task Force, and Director. 
Office of Program Developmenl and Evaluation, oi'l'; John M. Carley, Assistant to Mr. Grandpierre; 
Ronald E. Dreer, Deputy Director. Technical Services Division, OPP; Douglas D. Campt, Associate 
Director, Registration Division, OPP; Richard J. Heuwinkel, Assistant to the Director, Registration 
Division, OPP; Dr. Martin li. Rogtrff, Associate Director for Science. Registration Division, OPP; Dr. 
William Weils, Chief, standards and Labeling Section n Division, OPP; and, Dr. William 

j. Deputy Director, Criteria and Evaluation Division, OPP. 
■■Subcommittee statT Interview of Dr. William Wells, member, "Gran* | d chief, 

and Labeling Section, Registration Division, OPP, July 80. 1! 
•committee staff interview ol Douglas D. Campt, member, "Grandpierre Task Port i 
Director, Registration Division, OPP, July 21, 1978. 

41 Note 4". supra. Mr. I I that one of the "basic decisions" was to group pesticide products 

containing similar chemical ingredients into "bate! 

upra. 
npra. 
<< Subcommittee staff Interview of Dr. William Wells, member, "Grandpiem ." and chief, 

i :id Labeling B< ction, Registration Division, OPP, Sept. 16, 1978. 

Dr. Martin li. RogofT. 'Grandpierre Task Puree/ 1 and 

le Director I I Division, OPF, Sept. 20, 1976. 

i of John M. Carley, who was a member of the "Grandpierre 
Force," and ■ the Reregistration Task Forct 1976. 

a chart \\ l iicl i refers to the "Review F< r Sufficiency Of Data,"and, 

d to brief Mr. Quarles and Mr. Train shortly after the "< 

Task Forcp" met; (2) fun to the "validation" of d I bj Dr. 

ti. RogofT, who, following the work ofth< signed to bead the 

program; (3) a document prepi red bj John M, t arlej In March of 1975, which refers to the 

"review ency of data" as being a "scientific review of the data . . . \> ind document 

1 quacy." 



15 

force that might indicate to an observer that data would be reviewed, 
the truth is that the person directly responsible for reregistration, 
Dr. Martin H. RogofT, who was also a task force participant, believed 
that reregistration: 

. . . meant that we were to confirm that the data was there, 

that there were no obvious adverse effects revealed in previous 

scientific reviews [of the data], that the dosage levels [in the 

animal feeding studies] were satisfactory, and that a no-effect 

level [of dosage] had been found. [But] [w]e didn't look at the 

raw data [from the safety testing animal feeding studies] . 48 

The decision, in effect, was to validate the presence of data submitted 

over the last 25 years b}^ pesticide manufacturers, and not the adequacy 

of the data. 

A clear example of EPA's failure to evaluate data resulted in the 
agency's determination that there was "sufficient" data for "full" re- 
registration of the pesticide 2,4-D. On April 8, 1976, EPA mailed re- 
registration guidance packages to manufacturers of 670 products con- 
taining 2,4-D for which more than 45 residue tolerances have been 
granted on such foods as dairy milk, eggs, poultn r , meat, corn, apples, 
vegetables, and citrus fruits. The guidance packages cited a 2-year rat 
and dog feeding study performed by FDA in 1963 49 as "sufficient" 
to satisfy the "chronic" safety testing requirements for reregistration. 
Yet, a summary report on the study in EPA's files slated that there 
was "increased tumor formation" in the rats/ John M. Carley, 
Manager of the Reregistration Task Force, stated that he doubts 
that the summary report was even read in the preparation of the 
guidance packages. 51 An independent pathologist, who reviewed the 
raw data on the study at the request of subcommittee staff, concluded 
that 2,4-D "is carcinogenic (cancer-causing) in rats." 52 

Missing and misplaced testing data 

In March 1975, Dr. Rogoff's reregistration task force, initially con- 
sisting of two EPA scientists, began preparing for the reregistration 
program. R. Bruce Jaeger, a toxicologist, and Dr. Nancy A. Beach, a 
chemist, were assigned to search the tolerance petition files, as well as 
other data sources to determine whether there were existing data that 
could be used to support reregistration of pesticides, and whether 
required data was missing (data gaps). 

In a subcommittee staff interview on July 13, 1976, Mr. Jaeger 
stated, 

We weren't asked [by Dr. RogofT] to review the data; we 

were asked to see if the data was there. And, at first, we weren't 

asked to cite the data references. 53 

Dr. Beach stated 54 that it was not until September 1975 that the 

task force was instructed to cite data references from EPA's own files 



« Subcommittee staff interview of Dr. Martin H. RogofT, Oct. 14. 1976. 

49 Report, "Pathological Changes in Rats Fed 2,4-Dichlorophenoxvacetic acid for Two Years," by 
Robert T. Habermann, D.V.M., FDA, Mar. 20, 1964. Report, "Pathological Changes in Hogs Fed 2,4- 
Dichlorophenoxyacetie acid for Two Years," by Robert T. Habermann, D.V.M.. FDA, Nov. .">. 1963. 

s° Summary, Hansen, W. H.,etal., Chronic Toxicity of 2,4-Dichlorophenoxyacctic acid in Rats and Dogs. 
Toxicol. Appl. Pharmacol. 20, 122-129, 1971. 

*t Subcommittee staff interview of John M. Carley, Manager, Reregistration Task Force, Registration 
Division, Office of Pesticide Programs, FPA, Dec. 4, 1976. 

s 2 Preliminary Review of Some Oncogenicity Studies for 2,4-Dichlorophenoxyacctic acid, Melvin D. 
Reuber. M.D., Dec. 1, 1976. 

« Subcommittee staff interview of R. Bruce Jaeger, July 13, 1976. 

« Subcommittee staff interview of Dr. Nancy A. Eeach, Oct. 12, 1976. 



16 

which included the title of the safety testing study and such other in- 
formation as who performed the study and when it was performed. As a 
result, the task force had to return to the same files a second time to ob- 
tain the necessary data references and add them to the 600 or 700 
chemical worksheets that had previously been done. The data refer- 
ences were needed for citation in reregistration guidance packages 
which later would be used to inform pesticide manufacturers of what 
was, and what was not, needed in the way of additional data for 
reregistration of their products. Not only were the instructions given 
to the reviewers clearly inadequate, but the very files they were to 
review were seriously disorganized. 

It was not until the summer of 1974 — 2 years after FEPCA — that 
the Office of Pesticide Programs made an effort to modernize its 
filing system in order to facilitate data retrieval. In the summer 
of 1974, OPP contracted with a private firm to develop a computerized 
data retrieval system. However, data file reviewers on the reregistra- 
tion task force complain that this effort to computerize the data 
may have caused more problems than it attempted to solve. The 
reviewers have indicated that the computer printouts, which are sup- 
posed to identify the specific location of data, are inaccurate. Often, 
data have been found to be misfiled, or missing completely. 

Ms. Elsie Kelly, a reviewer on the registration task force, stated: 

In one file folder I found recently, there was just a table of 
contents, and nothing else. . . . EPA doesn't give enough 
importance to the files. . . . The files are in a mess. 55 

Fa ulty preparation of guidance packages 

One apparent reason for the data files being in such disarray is that 
the Office of Pesticide Programs has assigned only two fulltime per- 
sonnel to manage the filing operation. 

By September of 1975, an additional five or six EPA scientists had 
joined the reregistration task force. And, in October, the task force 
further strengthened with the addition of 15 people temporarity 
tied for 90 days (90-day detailees) from the four Divisions in the 
Office of Pesticide Programs. These additional personnel were brought 
in to begin writing the reregistration guidance packages which would 
be sent to pesticide manufacturers. 

In a memorandum dated October 8, 1975, Douglas D. Campt, 
Associate Director for the Registration Division, feted schedules for 
completing 15 guidance packages per week, with the first set of 
packages due on October 27, 1975. In addition, the memorandum also 
listed the "Inputs and Actions Required from [the] Reregistration 
Task Force. " Among them was: 

4. Providing data references for products contained in [pesti- 
cide product] batches and subbatches. This should include a 
batemenl that the data referenced has been considered and it 
has been determined that products in the batch can be reregistered 
based upon this data. M 
However, as pointed out earlier in this report, the data was not truly 
"considered/ 1 Nevertheless, the task force took the data references 

»» Bobeommttfe i lUll Intcrvtew of Ms. Btak K«-iiy. Sept. 9, 1978. 

inn. dab <1 Oct. 8, 1975. from Douglai D. < axnpt, A sso< late Director for RcElstratton KclMs- 
.:,, OPP, toJohn B. Bitch, Director, Registration Divi ton, OPP. ' 






17 

that had been recorded on the chemical worksheets and used them in 
its first effort to draft guidance packages. 

Meanwhile, Dr. Rogoff, with assistance from Dr. Orville E. Paynter, 
Chief, Toxicology Branch, Registration Division, OPP, and Dr. 
Lamar B. Dale, Chief, Metabolic Effects Branch, Criteria and Evalua- 
tion Division, OPP, had been determining from the chemical work- 
sheets which data was "sufficient" and which data was required (data 
gaps) for reregistration. In addition, Dr. Rogoff also had made deter- 
minations on whether data requirements could be waived, as is pro- 
vided for in FEPCA. 67 

Dr. William Wells, Dr. Rogoff, and Mr. Campt met on January 13, 
1976, to select a number of the 45 guidance packages completed by 
the reregistration task force for mailing to pesticide manufacturers. 
Although February 2, 1976, had been set as the target date for the 
first mailing, the January 13 meeting revealed fundamental defects 
in the reregistration program. 

Dr. Wells described the problems as follows : 

We saw that it wasn't possible for us to recommend sending 

any of the packages out. It was a big surprise to us. We found 

totally unacceptable data citations, [required] data had been 

waived with no justification, and the bibliographies [listings of 

acceptable data and data gaps] were totally inadequate. 58 

Mr. Campt stated, "[The guidance packages] were badly done, 

resulting in months of work being wasted. " 59 Dr. Wells stated that, for 

all practical purposes, the reregistration program was halted on 

January 13, 1976, because of the unacceptable guidance packages and 

other problems which came to light in rapid succession. 60 

On January 14, 1976, John B. Ritch, Director of Registration 
Division, called a meeting "to review progress made toward sending 
out the first call-in [guidance] packages on February 2." 61 John M. 
Carle}^, Office of Program Development and Evaluation, OPP, was 
among the seven who attended the meeting. 

According to a memorandum written by Mr. Carley on January 14, 
1976, Mr. Campt and Drs. Wells and Rogoff reported to the meeting 
what they had found the da}^ before in their review of the 45 guidance 
packages which had been reported to be complete. Mr. Carley's 
memorandum stated : 

b. Nine commonly occurring deficiencies [were found], of 
which the most serious were inadequate rationales for waivers of 
data, questionable bibliographies of supporting data citations 
(e.g. citations of summaries of RD [Registration Division] re- 
views vice [instead of] citations of the data reviewed, question- 
able interpretations of the applicability of conditional long-term 
[safety testing] data requirements, . . . C2 



m Pub.' L. 92-516, Oct. 21, 1972, 7 U.S.C. 135 states as follows: 

The Admi nistrator may exempt from the requirements of this Act by regulation any pesticide which 
hedetermi nes either (1) to be adequately regulated by another Federal agency, or (2) to De of a character 
which is unnecessary to be subject to this Act in order to carry out the purposes of this Act. 

w Note 44, supra. 

89 Note 40, supra. 

80 Note 44, supra. 

61 Memorandum dated Jan. 14, 1976, from John M. Carley, Office of Pesticide Programs, to Edwin L. 
Johnson, Deputy Assistant Administrator for Pesticide Programs. 

" Ibid. 



18 

Mr. Carlcy's memorandum further stated that there had been 
"serious problems" in "recruiting and training" of the task force, 
as well as in: 

B. Supervision: 

The various individuals on the task force have had to decide 
for themselves what to do and how to do it. Assignments have been 
of one individual [regardless of his background] to one chemical, 
to follow it all the way through. This had led directly to the 
wide variations in quality. . . . This has caused the existing 
packages to be virtually unreadable piles of miscellaneous bits 
and pieces; it's nearly impossible to tell what's there. 

C. Quality Control: 
There isn't any. . . . w 

Dr. Wells stated 64 that the discovery of deficiencies in the guidance 
packages led to a meeting C5 on January 15, 1976, to discuss the draft 
of the first "call-in Federal Register Notice" which was soon to be 
published. The "Notice" had been prepared by Dr. Rogoff. Basically, 
the purpose of the "Notice" was to inform pesticide manufacturers 
which pesticide chemicals had "sufficient" data required for "lull 
reregistration" (category I), and which did not (categories II and 
III). Dr. Wells said the meeting was held because, as he put it, "we 
didn't know if all the [pesticide] chemicals listed in category I [in the 
draft Federal Register Notice] belonged there." 66 

Dr. Wells said that on January 21, 1976, he and Mr. Campt ex- 
amined the chemical worksheets from which the information in the 
draft "notice" had been drawn, and on January 22, 1976, recommended 
that the "notice" not be published in its then present state. 67 

Mr. Campt stated that the review of the chemical worksheets 
revealed that a number of the pesticide chemicals listed in category I of 
the draft "call-in Federal Register Notice" as being "ready" for "full 
reregistration" had to be shifted to categories II and III, indicating 
that additional data was required, or to category V, indicated that the 
data on the chemical had not yet been "assessed." He said it was then 
that he and Dr. Wells realized how superficial the review of the safety 
testing data files had been. 

A hand-written document, entitled "Campt-Wclls-Quick Review 
of Worksheets — Jan. 1976," questioned numerous data waivers on 
pesticide chemicals that had been proposed by Dr. Rogoff. 

John M. Oarlev who at that time was in the Office of Program 
Development and Evaluation, OPP, recalls that at least 180 of the 
peel iciae chemicals had to be removed from category I. 68 

However, a special team was put to work on the guidance packages, 
and 8 or 10 were salvaged and mailed out during the first week of 

February 1970. And the "call-in Notice" 00 also was hurriedly re- 
worked and published in the Federal Register <>n February 17, 197G. 
Mr. Carley Btated that there were other "questionable" chemicals 

which should have been removed from category J before publication. 
"Ibid 

M \ o) 

ndlng the January 15, 1976 meeting were: Dr. Wells; Mr. Campt; l>r. Rogoff; Or .Jay Ttfflm, Dep- 
uty Director, Office of K< I I ktrs, OPP; [rwln Auerbach, Program analyst, Office 
in. I Policy Affairs, OPP; and Ronald K. Drear, Acting Director, Office of Special Pi 
•PP. 
« Not 

• : Note 44, supra, 
upra. 
i "Data RequbemenU t<> Suj^^.ti Registration (and Rereaistration) of Pesticide Active Ingrrdunt.- and Vre- 
Uminarf 8cheauUoj Catt-Ine, Pesticide Programs, Environmental Protection Agency, ratkral Roaster, 
Feb. 17, 



19 

but, he added, "there wasn't time enough, and some slipped through 
the cracks." Mr. Carley further stated that, in addition, the data gaps 
listed in the "notice" also were "fouled up". 70 

Reorganization oj registration task force 

On March 9, 1976, John B. Ritch, Director, Registration Division, 
relieved Dr. Rogoff as head of the reregistration task force, and put 
Mr. Carle} r in charge. 

Mr. Carley reorganized the task force in an effort to increase 
efficiency and productivity. A new and more permanent group of 
personnel were assigned to the task force to replace the first group of 
90-day detailees who had returned to their respective permanent 
positions. 

The task force still was faced with an almost impossible task of 
completing reregistration by October 1977, 71 and they had to do so 
in the face of the disorganized and incomplete data files, inaccurate 
data computer printouts, insufficient personnel, and inadequate scien- 
tific expertise among the personnel. And, because of these constraints, 
there still was no serious attempt to validate the adequacy of the safety 
testing data that would be accepted for reregistration of pesticides. 

Ms. Elsie Kelly, one of only four toxicologists assigned to the task 
force, stated: 

You can't expect our [data] reviewers who have a fish and 
wildlife background to evaluate a 2-year [animal] feeding stud}' 
[to determine if the results showed cancer]. We can't do a thorough 
job on reviewing the data. We are playing games with side effects 
from pesticides, and with the food for the population. 72 
In a memorandum dated July, 1976, Alejandro Arce, a task force 
reviewer, stated to John Carley, manager of the task force : 

I believe that you know the problem, [and] so does every- 
body .... The most disturbing thing is to see that no one, or 
very few of us have the courage to admit that there is a problem 
and be frank about [it] and try to solve it in the proper way . . . 
Our problem is data. Our DATA is poor[,] disorganized, inac- 
curate, lacking!,] etc. [A]nd REREGISTRATION is nothing 
more than finding the right data .... Out of every 100 pages 
of data[,] a very low percentage (I will not dare to say how low) 
is usable, understandable or scientific. . . . Do we have to 
accept the data as it is, or do we have the right to comment, and 
invalidate it, if it is inaccurate? There are many unanswered 
questions about DATA, and while they are unanswered!,] we 
will not be able to do the job. 73 
Mr. Arce stated to subcommittee staff: 

I knew things were being done wrong 6 months ago. : : ; 
The first thing we must do is organize the files. Until we do that, 
it is impossible to validate the data. 74 



70 Note 46, supra. 

71 Note 14, supra. 

72 Subcommittee staff interview of Ms. Elsie Kelly, toxicologist, reregistration task force, Registration 
Division, OPP, Sept. 9, 1976. 

73 .Memorandum dated July 1976, from Alejandro Arce, reviewer, reregistration task force, Registration 
Division, OPP, to John M. Carley, manager, reregistration task force. 

74 Subcommittee staff interview of Alejandro Arce, reviewer, reregistration task force, Registration 
Division, OPP, Sept. 9, 1976. 



20 

William Rabert, a biologist and data reviewer on the task force 
stated: 

I can cite a report [from the files] on a chronic feeding study, 
but I can't evaluate it. This should be given to a toxicologist. 75 
While there were improvements in the operation of the reregistration 
task force beginning in March 1976, most of the improvements were 
of a clerical nature, 76 and had virtually nothing to do with validation 
of pesticide safety testing data by the task force. Yet in hearings 
held by the Senate Subcommittees on Health and Administrative 
Practice and Procedure on January 20, 1976, John R. Quarles, Jr., had 
acknowledged that 

. . . there are indications that serious problems may exist . . . 
in the conduct of pesticide [safety] testing. 77 

Treatment of "svspect" pesticides 

Shortly after EPA's Reregistration Task Force had gotten off to its 
disastrous first start, the agency reorganized and redirected its pro- 
gram to suspend and cancel (or reclassify) those pesticides suspected 
of causing harmful effects. The Office of Special Pesticide Reviews 
(OSPR), established in December 1975, was given the task of assuring 
thorough review of these "suspect" pesticide chemicals. OSPR 
replaced the Suspect Chemical Review Program which had already 
completed, or was near completing, evaluation of 70 "suspect' 
pesticide chemicals, 78 some of which had been under review since 
197 1. 79 Since the creation of OSPR in late 1975, an additional 62 
pesticide chemicals have been added to the "suspect" list, bringing 
the total to 133. 

A lengthy procedure 80 was developed by OSPR to determine, 
firsl of all, whether the continued use of a "suspect" pesticide chemical 
should be challenged through issuance of a "rebuttable presumption 
against registration" (RPAR), or cleared for reregistration, and 
secondly, if a RPAR were issued, OSPR must coordinate and manage 
an indepth risk-benefit analysis of the use of the "suspect'' chemical. 
Following the analysis, the Administrator weighs the risks against 
the benefits to determine whether the pesticide should be reregistered, 
or removed from the market (or reclassified). But, like the Rereg- 
istration Task Force. OSPR also has bad serious difficulties. As late 
to July 197G, 81 EPA proj'eeted that by December 197G, OSPR would 

n Subcommittee staff interview of William Hubert, reviewer, reregistration task force, Registration 
Division, OPP, Sept. 't, 1976. 

»The reregistration tusk force, as it, was reconstituted in March 197«, initially spent muoh of its time 
repairing and redrafting the 46 reregistration guidance packages w inch bad been found to be seriously defi- 
cient and lacking in uniformity in January L976; and a "review panel" was created U) check the nack- 
agefl for such things as uniformity and justifications tor (lata waivers. 
ipra. 

"* Memorandum dated I >■■(■. '), 1976, from the 1 >eput v Assistant Administrator, OfflCC of Pesticide Pro- 
grams, to the Administrator. Ki'A. The pesticides for w hich reviews had been completed, or were a* 

. • I 2,4,5-T (39 chemicals); Anmk (16 chemicals); Lead (one chemical); Betutne Hexachloridt 
(one ch< il) ; Endrin > I); Strata* (one chemical); Taxtpkem (one 

chemical); Carbaryl (one chemical); DDVP (ono chemical); Chlorobemilate (one chemical); EBDi 

Chemical I; and Pidoram (one chemical). 

n Memorandum d from the Deputy \ Administrator, Office of Pesticide Pro 

to the Administrator, EPA. Pesticides under review since r»7i Included: 2,4,6-T (89 chemicals); 
.1 lead (one chemical). 

as much as 90 days for thi "prj RPAR" period, during 
ectad and analyzed, and collection of ben. nts data is begun; if a RPAR Is issued, the 
next iso ... the manufacturer of the pesticide chemical an opportunity toiebut the RPA R 

throm!. i I litional data, for collection of benefits data, and for EPA to perform t 

the next 60 d k benefll ai 'lien glvsn to U8DA, the 8ci< nee Advisory 

Board, the Sci< Me.- Advisory Policy ('on. mitt".' when appropriate, and the appropriati House and Senate 
Committee Staff tor review and comment-; and an additional 80 days is provided for the Ad mi nisi: 
ion whether he intends to cancel or propose registration of the pesticide chemical. 
»' rpa ii candidate schedule, prepared by the "thee oi Special Pesticide Reviews, July 1976. 



21 

have decided whether to challenge through the RPAR process the 
continued use of 65 of the 133 "suspect" pesticide chemicals, or clear 
them for registration. However, as of December 8, 1976, EPA had 
issued RPAR's on only nine pesticide chemicals; two chemicals 
were cleared for reregistration ; and voluntary cancellations of five 
pesticide chemicals were obtained from manufacturers. 82 

A December 9, 1975 memorandum from the Office of Pesticide 
Programs (OPPj to Mr. Train proposing the creation of the Office of 
Special Pesticide Reviews, stated: 

Pesticides which have already undergone intensive internal 
review are scheduled for expedited action; the}' will be processed 
as rapidly as possible . . ,. 83 
The memorandum further stated : 

Federal Register notices announcing either thai the pesticides 
(36 chemicals 8! ) will be registered or that a rebuttable presump- 
tion against registration exists will be completed prior to J/17 76. 85 
However, as of December 8, 1976, some 11 months later, decisions 
had not yet been made on whether RPAR's should be issued on 31 S6 
of the 36 "suspect" pesticide chemicals in order to determine whether 
they should remain in use. 

In the case of EBDC's, consisting of six of the 31 "suspect" chemicals 
for which a decision on RPAR has yet to be made, EPA scientists 
first recommended * 7 revocation of EBDC's residue tolerances on foods 
and cancellation of the use of EBDC's on food crops in 1971. Ethylene 
thiourea (ETU), a degradation product of EBDC's, is a carcinogen, 
and there presently are more than 70 tolerances established for 
residues of EBDC's on such foods as beans, cabbage, lettuce, tomatoes, 
peppers, celery, bananas, grapes, and apples. Moreover, it is important 
to point out that the issuance of a RPAR on EBDC's, or any "suspect" 
chemical, only initiates the length}* RPAR process of risk-benefit 
analysis, and does not remove the pesticide chemical from the market. 
When OSPR was first created in December 1975, it appeared as 
though it would be given high priority. However, the support given 
to OSPR, until recent months, indicates otherwise. Although EPA 



82 As of December 8, 1976, those pesticide chemicals for which RPAR's have been issued are: (1) E 
(one chemical); (2) Chloroform (one chemical); (3) Chlorobenzilate (one. chemical); (4) Endrin (one chemical); 
(5) BHC (one chemical); (6) Strychnine (one chemical); (7) Strychnine Sulfate (one chemical); (8) 1080 (one 
chemical): and (9) 1081 (one chemical). 

As of December 8, 1976, those pesticide chemicals returned to the Registration Division are: (1) Pidoram 
(one chemical) and (2) Sp'rm Oil (one chemical). 

As of December 8, 1976, those pesticide chemicals for which OSPR obtained voluntary cancellations from 
manufacturers are: (1) OMPA (one chemical); (2) Strobane (one chemical); (3) Aramite (one chemical); (4) 
Kepone (technical gradr); and (5) BHC (technical grade). 

"Memorandum dated D«c. 9, 1975, from the Deputy Assistant Administrator, Office of Pesticide Pro- 
grains, to the Administrator. EPA. 

M The pesticide chemicals listed in the memorandum Included: Strobane (one chemical); Toxaphme (one 
chemical); Carbaryl (one chemical); BHC (one chemical); Lindane (one chemical); Endrin (one chemical): 
Pidoram (one chemical); EBDC's (6 chemicals); Lead (one chemical); and Arsenic (22 chemicals). 

"Memorandum dated Dec. 9, 1975, from the Deputy Assistant Administrator, OUice of Pesticide Pro- 
grams, to the Administrator, EPA. 

■ The 31 pesticide chemicals for which decisions on RPAR had not yet been made as of I >ec. 8, 1976, ai e 
Toxaphene (one chemical); Carbaryl (one chemical); Lindane (one chemical): EBDCi (sii chemicals) 
(one chemical); and Arsenic (21 cb"micals). 

* 7 Memorandum dated Oct. 5, 1971, from Drew M. Baker, Jr., Chief, Petitions Control Branch. Pesticides 
Tolerances Division, EPA, to K. J. McFarland, Acting Director. Pesticides Tolerances Division, EPA. 
Memorandum dated Oct. 5, 1971, from Clara H. Williams. Ph.D., Chief, Toxicology Branch, Pesticides 
Tolerances Division, EPA. to Frank J. McFarland, Acting Director, Pesticides Tolerances Division. 
Memorandum dated Oct. 7, 1971, from F. J. McFarland, Acting Director, Pesticides Tolerances Division. 
El'A. to Dr. William M. Opholt, Deputy Assistant A.dministi ticides Programs, EPA. 



79-661-76 4 



22 

had authorized 43 positions for OSFR in April 1976, it was forced to 
operate for 9 months, through September 1976, at only 25 percent of 
its authorized strength. Ronald E. Dreer, Acting Director of OSPR 
since its creation, states that OSPR also has had serious difficulty in 
obtaining on a timely basis thorough reviews of safety testing data 
relating to human health hazard from the Criteria and Evaluation 
Validation Committee. 88 OSPR relies upon the validation reviews in 
determining whether to issue RPAR's. 

As a result of inadequate priority and resources given to OSPR, 
evaluation of "suspect" pesticide chemicals, some of which were 
identified years ago, has been still further delayed. 

CONCLUSIONS 

Poor planning and management with respect to pesticide regulation 
within EPA is illustrated by: 

(1) the lengthy delays in organizing its reregistration program; 

(2) the policy decisions of top agency officials to take shortcuts, 
expecially the decision to restrict the scope of health hazard evaluations 
which could not be supported by data in the agency files; 

(3) the failure to adequately assemble and organize the agency's own 
files on safety testing data; 

(4) the failure to remove from critical data review positions personnel 
who lacked adequate expertise to perform the scientific analyses 
required ; 

(5) the failure to correct the woeful inadequacies as they came to 
light; 

(6) EPA's slowness in giving adequate priority and resources to 
ilf Office of Special Pesticide Reviews; and 

(7) the failure to inform the Congress and the public that the 
agency, largely because of resource constraints, could not adequately 
evaluate the safety testing data for reregistration of pesticides. 

EPA today still lacks the resources, personnel and capability to 
perform the statutory requirement of ensuring the safety of pesticides, 
while at the same time performing speedy registration and 
reregistration. 



dilation Validation Committee i^ made up of tho branch chiefs of the Criteria end 
evaluation Division, Office of Pesticidt Programs, EPA. 



III. LENGTHY DELAYS IN CORRECTING SERIOUS 
PROGRAM DEFICIENCIES 

Regulation of pesticide use by the Federal Government is critically 
dependent on the safety testing data submitted by the firms that 
manufacture and market pesticides. EPA's pesticide program cannot 
even begin to fulfill its purpose if the data upon which it relies for 
regulatory decisions are deficient, incomplete, or otherwise faulty. 

EPA almost exclusively relies upon data submitted by the pesticide 
companies. This data is the informational linchpin in the agency's 
regulatory program. Yet, in spite of repeated warnings beginning at 
least 5 years ago that the data it was relying upon was faulty, EPA has 
failed to take corrective action designed to discover and supplement 
faulty data. Attempts to improve these program deficiencies have 
fallen victim to unnecessary delays. And, as a result, the pesticide 
reregistration program is in a state of chaos, and the American people 
cannot be reasonably assured that the Federal Government is pro- 
tecting them from pesticides that pose a serious threat to their health. 

Early warnings went unheeded by EPA 

Official criticisms of the adequacy of data and data reviews used to 
support Federal approval of pesticides began many years ago. In 
1969, the House Committee on Government Operations issued a re- 
port, u Deficiencies in Administration of Federal Insecticide, Fungicide, 
and Rodenticide Act" (Fountain report), 89 which strongly criticized 
the administration of the pesticide laws by USDA. The report, among 
other things, concluded: 

Numerous pesticide products have been approved for registra- 
tion over objections of the Department of Health, Education, and 
Welfare [FDA] as to their safety without compliance with re- 
quired procedures for resolving such safety questions. 90 
The report recommended that "USDA take prompt action to make 
certain that pesticide products are not registered or reregistered unless 
there is adequate assurance that they are safe and effective. " yi 
As a result of this criticism, regulation of pesticides was transferred to 
the newly created EPA in 1970. Also in 1969, the Report of the [HEW] 
Secretary's Commission on Pesticides and Their Relationship to 
Environmental Health (Mrak report) 92 was published. This report 
criticized the adequacy of data which had been accepted to register 
pesticides by concluding that much of this data did not demonstrate 
that the chemicals posed no serious human health hazards, and ac- 
cordingly recommended that "immediate steps be taken to require 
orderly testing of tumoragenicity" of many specific pesticides. y:; 

^"Deficiencies in Administration of Ftdtral Insidieide, Fungicide, and Rodenticide Act," l>y the House 
Committee on Government Operations, based on a study made by its Intergovernmental Relations Sub- 
committee, L. II. Fountain, Chairman, Nov. 13, 1969. 

•o Ibid. 

w Ibid. 

" Report of the Secretary's Commission on Pesticides and Their Relationship to En viivnriu ntal Health, 
Parts I and II, U.S. Department of Health, Educatiou, and Welfare, December 1969. 

•» Ibid. 

(23) 



24 

Following these official warnings of data deficiencies, EPA's own 
limited actions confirmed the inadequacies of existing pesticide safety 
ing data. 

One of the earliest warnings arising out of EPA's own limited ac- 
tions came as early as 1971, when the agency's own review 91 revealed 
deficiencies in the data that had previously been used to register the 
pesticides Aldrin and LHeldrin and lieptachlor. The review showed 
thai the three pesticides had the potential for causing cancer, and 
ultimatelv led to the removal of Aldrin and LHeldrin from the market 
in October 1974. 93 

In 1974, an EPA review 90 of data, which had previously been ac- 
cepted by EPA as proving the safety of the pesticide Chlordane, 
revealed that the chemical in fact had the potential for causing 
cancer. Most nses of Heptachlorj Chlordane were suspended in Decem- 
ber 1975. 9: 

ived formal ami additional warning in the Late summer 
of 1975 from the General Accounting Office in a report which 
concluded : 

Adequate data supporting the safety of many pesticide toler- 
ance^ have not been submitted, and data on many pesticide 
•dues is not available. 98 
The (iAO report recommended that EPA review the "adequacy" 
of the data used to support "all existing tolerances," and that the 
agency "require manufacturers to submit any missing data." 99 
! 1'A agreed with GAO's criticisms, and stated that it would iniple- 
qX the recommendations. 100 

It is important to point out that much of the very same data which 
have been relied upon over the past 22 years to make findings of the 
safety of pesticide residue tolerances also have been used to support r< - 
■ ration of pesticides. Nevertheless, as pointed out in section 11 
of this report, the review of the data for reregistration, from the 
beginning of the reregistration program in October 1975 to it> collapse 
in Auglisl 197G, has been at best superficial. And EPA has yet to begin 
a systematic review of the more than 4,000 existing tolerances for 
:diies on numerous food and I'ced commodities. 

Red i Uions of "serious problems" in safety testing 

In early January 11)70, shortly before reregistration was halted he- 
cause <>f superficial data review, the subcommittee invited John EL 
Quarles, dr., Deputy Administrator of EPA, to testify at beari 
icheduled for January 20, 1076. Mr. Quarles waa invited to testirj 
along with representatives of the Food and Drug AdministratioB and 
the National Cancer Institute. Previous joint inquiry by the >ul>- 
committees on Health and Administrative Practice and Procedure 
into FDA'fl approval of new drugs had revealed that the report- to 
i'DA (.n safety testing of drugs in animals performed by at least two 

bology consultaul i<> EP \. reviewed i in- tissue slides from animal I 
rteMrin and Heptacloi In 1971 .a the requesl of EPA. 

ispended by order of the Idmii BPA, Oot. 1, 

1 1), i: utx ultant to EPA, reviewed the tissue slides from animal feeding 

BPA. 

( (if /!> iil'iclUtiTlt'ltlordunt led 1>\ order Of the Adininist: 

inistrator, BPA, Jan. 19, 1970, 41 P.R.7652, Feb. 19, 1976. 
-, 
[bid 

ided i" the < • a< » draft report la i lei iy75. 



25 

private laboratories were suspect. Like FDA, EPA relies upon reports 
from private laboratories to determine whether pesticides released 
into the environment have the potential for causing harmful effects. 

Shortly before Mr. Quarles was to testify, EPA's Office of Pesticide 
Programs (OPP) hastily organized an effort "to make a preliminary 
determination as to whether there [was] any evidence of irregularity 
or impropriet}^ in pesticide testing." 101 An "action plan" called for a 
"small group" of EPA and outside scientists to review pesticide safety 
testing reports submitted by manufacturers on the 43 pesticide active 
ingredients for which residue tolerances had been established on "the 
greatest numbers of (food and feed) commodities." 102 

Dr. Melvin D. Reuber, a pathologist consultant to EPA, verbally 
presented the preliminary findings of the data review to a group of 
agency personnel who were preparing Mr. Quarles' testimony. Dr. 
Reuber told the group that the review thus far had revealed such 
deficiencies as inadequate pathology (lack of adequate examination 
of tissue from animals fed the pesticides in tests), poorly tabulated and 
summarized data, and insufficient data from which to make a judg- 
ment. He advised the group that review of the data should be pursued 
further. 103 

Mr. Quarles gave the following testimony before the subcommittee 
on January 20, 1976: 

[T]here are indications that serious problems may exist. For 
example, in recent hearings on Heptachlor/Chlordane 104 and 
Aldrin/Dieldrin, 10 * we found that many of the laboratories which 
had completed chronic toxicity [safety testing] studies performed 
extremely conservative histologic examinations. In virtually 
every instance, independent pathologists diagnosed many more 
cancerous and precancerous tumors in the test animals than did 
the original laboratory pathologists. 

These situations coupled with a recent preliminary review of 
several toxicity studies submitted to EPA have alerted us to the 
possibility of serious deficiencies in the conduct of pesticide 
testing. 106 

Mr. Quarles failed to mention that some of these "indications" of 
"serious problems" dated as far back as 1971. 

Mr. Quarles further testified: 

We . . . have now undertaken a crash effort which we will 
attempt to carry out within the next 4 to 6 weeks . . . [and] 
primarily we will be conducting reviews of the test data that we 
have. 107 



101 Memorandum dated January 1976, from Edwin L. Johnson, Deputy Director, Office of Pesticide Pro- 
grams, to Alvin L. Aim, Assistant Administrator for Planning and Management, EPA. 

'<» Ibid. 

103 Subcommittee staff interviews of Dr. Melvin D. Reuber, consultant to EPA, on Feb. 6, 1976, and Oct. 
12, 1976. 

m EPA conducted administrative hearings from August 1975 to December 1975 on the proposed sus- 
pension of Heptachlor/Chlordane uses. Administrative hearings for cancellation of Heptachlor/Chlordane 
uses began in February 1975, and are still continuing. 

'W EPA conducted administrative hearings from April 1971 to August 1974 on the proposed suspension 
of Aldrin/Dieldrin uses. Administrative hearings for cancellation of Aldrin/Dieldrin uses were held from 
July 1975 to February 1976. 

108 Testimony of John R. Quarles, Jr., Deputy Administrator, Environmental Protection Agencv, before 
joint hearings by the Subcommittee on Health and the Subcommittee on Administrative Practice and 
Procedure, Jan. 20, 1976. 

»« Tbid. 



26 

"Crash program" is scaled down 

Following; the hearings, EPA set up a ''Working Group on Pesticide 
Testing." l6s On February 9, 1976, the Chairman of the new Working 
Group recommended that a group of scientists and statisticians 
examine testing reports "on 5S randomly selected pesticide chemicals 
... for winch residue tolerances [had] been established,'' and that 
fo 1 lowing the examination of the test reports, the findings should be 
compared with the previous reviews for tolerance setting in order 'to 
determine the extent to which the original reviewers [at FDA and 
EPA] identified the same errors and to ascertain the action taken in 
such cases." 109 

On February 11, 1976, at the first meeting of the Working Group, 
"concern" was expressed over the data being used for reregistration of 
pesticides. 110 

Then, on February 17, 1976, FDA suggested to EPA that, based 
on FDA's experience, an audit of test records at the laboratories 
would prove to be more fruitful than a review of test reports only. 111 
And following that meeting, EPA expanded its plan to include a 
laboratory audit plan. 

Subsequently, Mr. Quarles commitment to the subcommittee on 
January 20 to undertake a "crash effort" to conduct reviews of test 
data in EPA's files was scaled down considerably. As it turned out, 
Dr. Reuber alone was assigned to examine the files on only 23 of the 
originally chosen 58 pesticide chemicals. Moreover, Dr. Keuber was 
not assigned the task until mid-February, almost a month following 
the January 20 hearings, and he was able to spend less than 3 weeks 
reviewing the safety testing reports. 

Serious problems in safety testing are confirmed 

Dr. Reuber revealed to the Working Group on March 11, 1976, 
that, even in his very limited and scaled down review, he had dis- 
covered an alarming number of serious deficiencies in the testing 
reports, as well as a lack of sufficient data from which a judgment 
could be made. Among the deficiencies he noted were: (1) too few- 
animals used in some of the tests; (2) incomplete examination of the 
animal tissue; and (3) in one study, the number of rats at the end of 
the test period was larger than the number of rats at the beginning of 
the test. 112 Dr. Reuber's findings further confirmed in more detail what 



morandum <iat*-<i Jao. 22. 1976, from Edwin L». Johnson, Deputy Assistant Administrator, Office of 
Pesticide Programs, to Or. Roy Altx rt, Chairman, < lancer Assessment < (roup, BPA, Alvin L. Aim. 

Lministrator for Planning and Management, BPA, Jeffrey E. Uowai t General Counsel, 

BPA, Augustine E. Conroy, li, Director, Pesticides Enforcement Division. Office of Enforcement, 
hi' \. and John B. Bitch, Director, Registration Division, ore. EPA. 

Members of the W up Included: Erwln L. Auerbacn, Chairman of the Working Group and 

Program Analy it for OPP; Dr. Orvllle E. Paynter, chief, Toxicology Branch, Registration Division, OPP; 

Dr. William ll. Preston. Deputy Dii riteria and Evaluation Division, OPP: Anthom 

Planning and Evaluation, Office of Planning and Management; Doreen Bill, Health 

Effects Officer, Office of Research and Development; Bingham ETennedy, staiT attorney. Office of Gi 

netb Gutterman. I Ides Enforcement Division, Office of Enforcement; and 

er Bchuth, Bdenti roxlc Sub I i 

morandum dated Feb. '.», 1978, from Irwin L. Auerbach, Chairman, Working Group on Pesticide 
ig, and Program Analyst, OPP, to I Icing < troup on Pesticide Testing. 

30. 1978. from Ms. Carter Bchuth, member. Working Group on Pesticide 
t, Oilier of Toxic Substanoes, i PA, to Dr. Michael J. Prlval, Acting Chief, Chemical 

Branch, Ofllce ol I s, EPA. 

'" Memorandum dated "week om Anthony D. Cortese, member, Working Group on Pesticide 

, to Alvin L. Aim, Assistant Administrator for Planning and Management, BPA. 
iboommittee stall Interviews ol Dr. Melvln D. Reubor, pathology consultant to EPA, on M:ir. . r ., 
1976, and Oct. 12, l 



27 

he and three other scientists had previously discovered prior to the 
January 20 hearings. 

However, Dr. Reuber was never asked to examine the prior re- 
views performed by FDA and EPA scientists relating to the testing 
reports on the 23 pesticides he had evaluated. The purpose for ex- 
amining the prior reviews, contained in the "correspondence files," 
as the chairman of the Working Group on Pesticide Testing had 
stated in his memorandum of February 9, 1976, would have been 
"to determine the extent to which the original reviewers identified 
[deficiencies in the test reports]," and more importantly, "to ascertain 
the action taken in such cases." 113 

In the meantime, by March 11, 1976, the reregistration task force, 
without having evaluated the previously submitted data, had already 
mailed to manufacturers guidance packages for 393 pesticide products 
advising that existing data was "sufficient" for reregistration, and 
which additional data was required. 114 And of the 393 products, 136 
relied upon data which Dr. Reuber's scaled down review had found 
deficient. 

The Working Group on Pesticide Testing met for the third time on 
March 17, 1976. Among those in attendance were Dr. George Whit- 
more of the Registration Division's Toxicology Branch, and Dr. 
Martin H. RogofT, who had been relieved as head of the Reregistra- 
tion Task Force on March 9, 1976. A memorandum by Ms. Carter 
Schuth, a member of the Working Group, stated that at the meeting : 

[Drs. Whitmore and RogofT] both objected strongly to Reuber 's 
findings. Whitmore [said] that the data [is not] as bad as Reuber 
described. . . . [Dr. RogofT] assured the Work Group members 
that all the problems that have been mentioned are being taken 
care of in the reregistration process. 115 

Failure to follow up in a timely and adequate manner 

It was not until April 5, 1976, almost a month after Dr. Reuber had 
reported serious deficiencies in the testing reports to the Working 
Group on Pesticide Testing, that there was any attempt to examine 
the correspondence files which contained prior reviews of data sub- 
mitted by manufacturers. One person, Ms. Carter Schuth, a member of 
the Working Group, was assigned to review only a small sampling of 
correspondence files in preparation for Mr. Train's testimony before 
this subcommittee scheduled for April 9, 1976. On April 7, 1976, 
Ms. Schuth reported 116 her findings which indicated that FDA and 
EPA scientists, in prior reviews (some dating back to the early fifties), 
had discovered deficiencies l17 in the testing reports similar to those 

"3 Note 109, supra. 

im List of Guidance Packages Mailed to Registrants, dated Aug. 5, 1976, and issued by the Standards and 
Labeling Section, Registration Division, EPA. 
us Note 110, supra. 

111 Memorandum dated Apr. 7, 1976, from Ms. Carter Schuth, member, Working Group on Pesticide 
Testing, and scientist, Office of Toxic Substances, EPA, to Irwin L. Auerbach, Chairman, Working 
Group on Pesticide Testing, and Program Analyst, OPP, El'A. 
1,7 The deficiencies included: 

1. Low survival rate of experimental animals; 2. Premature sacrifice of animals or termination of experi- 
ment; 3. "Uneven" number of animals in (testing) groups; 4. Failure of petitioner to report statistical 
significance of differences in experimental (those fed the pesticide) and control (those not fed the pes- 
ticide) animals; 5. (Pesticide) (d)ose level too low; and 6. Inadequate histopathologic^ examination of 
(animal) tissues; questionable his'opathological findings; failure to report histopathology on all tissues 
sectioned; failure to perform histopathologic^ examination of tumors in control animals; and tumors 
termed benign without histopathologic;)! examination. 



28 

which had been cited by Dr. Reuber after his examination of the 
reports in late February and early March. But, prior to the April 9 
hearings, no attempt was made, as had been suggested on Feb- 
ruary 9, 118 to determine what action had been taken. 

The hearings on April 9, 1976, were held as a followup to the Janu- 
ary 20 hearings at which Mr. Quarles had testified that "there are 
indications that serious problems may exist" in pesticide safety test- 
ing and that EPA had "undertaken a (4 to 6-week) crash effort" 
to better determine the severity of deficiencies in previously submitted 
testing reports and data. 119 On April 9, 1976, Mr. Train submitted to 
the subcommittee an "interim" report on Dr. Reuber's review di 
safety testing reports in which Dr. Reuber stated that, because of 
"severe time restrictions placed on [his] effort," he had been unable to 
write an "in-depth review of each of the [pesticide] chemicals," and 
that he was unable to analyze whatever raw data was available on 
the tests. 120 An EPA "statement" attached to Dr. Reuber's report 
pointed out that FDA and EPA scientists, in prior reviews, also had 
cited deficiencies similar to those discovered by Dr. Reuber, and the 
>inent" went on to say: 

Such deficiencies commonly are the basis for EPA requests that 
petitioners (manufacturers) provide additional information and/ 
or clarification. 121 

EPA testified before the April 9 hearings as follows : 

Senator Kennedy. Can you tell us when the reviewers did 
pick those (deficiencies) up, (and) what action was taken? Did 
you consider that? 

Mr. [Edwin L.] Johnson. 122 We have considered it. That is 
an aspect, as I have indicated, we have not had sufficient time 
to get into in any detail. 

Senator Kennedy. Your reviewers found these discrepancies 

and you have indicated that many of the<e discrepancies were 

significant, but you are unable to tell us now what was really 

done about it after these discrepancies were found. Do I under- 

band you correctly? 

Mr. JOHNSON. 1 cannot tell you in detail what was done. 
That is one of the things we are looking into. 123 

Mi-. Train testified that EPA hoped to begin an "auditing program 
(by July 1, 1976] in which laboratory records of toxicity test reports 
will be examined to determine whether the;, accurately reflect the 
reported tesl procedures and results." 124 It was not until December 
n + 7 * i thai a limited pilot auditing program w finally got underway, 
in spite of the fact that by April !>, L976, EPA had gone ahead and 

loeompenylng note LOP, sup™. 

. m. 
ifToxicity T< 'uhiiiiti"fl in Support of ! iterance Petitions, by Melvin D. 

Reubtr, M.D., for the U.S. ] Api 

u-dlng Dr. Reuber's rei ort. Am. 9, hTW, 
EPA. 

y the Subcommittee on BTeatth and the Bubcommlttt n Admin 

■ \ 
Ibid. 

.'. contractor I 
PA i" fan negotiating with FDA to p< PDA was u 

n and could iry audits al alowei oosl than a private contract* 

informer] subcommittee stafl thai a "pilot" laboratory audit i i scheduled to begin on or about 

iber i, 1976, with a f uii icale program to follow In about 8 months. 



29 

mailed reregistration guidance packages to the manufacturers of 
1,257 pesticide products without having validated the testing data 
cited in the packages as being "sufficient.'' 

Following the April 9 hearings, the chairman of the Working 
Group on Pesticide Testing urged that EPA take the following action : 

Case histories on at least some of the pesticides covered by 
Dr. Reuber's review must be prepared. EPA can anticipate that, 
sooner or later, it will be called upon to specify what actions have 
been taken over the past 25 years on the basis of the test reports 
that Dr. Reuber reviewed. 126 

EPA's subsequent effort to answer the critical question of what 
action had been taken on deficiencies in testing reports and data was 
grossly inadequate. In mid-April, 1976, Ms. Carter Schuth, alone 
and on a parttime basis, was assigned to begin reviewing the corre- 
spondence files which contained the prior reviews of data by FDA 
and EPA scientists. 

EPA's belated examination reveals that agency failed to act on inadequate 
safety data. 

By early May 1976, EPA had uncovered some alarming facts in 
the first review of correspondence files pertaining to Methoxychlor, a 
pesticide chemical of which approximately 10-million pounds have 
been produced in the U.S. annually in recent years, and for which 79 
food and feed residue tolerances had been established since 1955. 
Ms. Schuth found that over the years prior reviews by FDA and EPA 
scientists had criticized the safety testing that had been done on the 
pesticide, as well as the interpretation of the testing results. In fact, 
on several occasions reviewers had called for repeating certain animal 
feeding studies in order to determine the safety of Methoxychlor, but 
apparently there was no followup by EPA. 127 Moreover, an FDA 
pathologist in 1969 had concluded, after reviewing a feeding study 
utilizing mice, that Methoxychlor was a carcinogen (cancer-causing), 128 
and in 1972 two EPA pathologists reached the same conclusion. 129 

Nevertheless, the 79 residue tolerances established since 1955 have 
thus far gone unchallenged by EPA, despite EPA's findings in other 
cases that there is no known safe level of exposure to chemical car- 
cinogens. Moreover, in October 1973, EPA granted a residue toler- 
ance for Methoxychlor in cow's milk for human consumption. 130 In 
addition, much of the very same data criticized in previous reviews 
was cited as "sufficient" in reregistration guidance packages that had 
been mailed on March 9, 1976, to manufacturers of 72 pesticide 
products containing Methoxychlor , 131 

By early June 1976, Ms. Schuth had completed a review of the 
correspondence files on Captan, a widely used pesticide chemical of 
which approximately 18 million pounds have been produced annually 

136 Memorandum dated Apr. 13, 1976, from Irwin L. Auerbach, Chairman, Working Group on Pesticide 
Testing, and Program Analyst, OPP, to Edwin L. Johnson, Deputy Assistant Administrator, OPP. 

i» Note 20, supra. Attachment No. 1, "Review of the Tolerance Correspondence Files for Methoxychlor." 
See appendix. 

'3 Memorandum dated Sept. 15, 1969, from Dr. M. Adrian Gross, Bureau of Science, FDA, to Dr. O. G. 
Fitzhugh, Toxicoloeical Adviser, Bureau of Science, FDA, "SUBJECT: Project 2-<103-04-Chronic Toxicity 
of Chlorinated Hydrocarbon Pesticides— DDT and Methoxychlor— Analysis of Pathology Results." 

•2» Note 127, supra. 

•so Ibid. 

'3' Note 114, supra. 



30 

in the U.S. in recent years and for which 70 food and feed tolerances 
have been granted for residues on such foods as apples, beans, carrots, 
lettuce, grapes, and corn. A notice 132 published by EPA in the Federal 
Register on February 17, 1976, had placed Captan in "category I," 
indicating that data previously submitted by the manufacturer had 
met all requirements for "full" reregistration. Yet, as in the case of 
Methoiychlor, prior reviews had criticized the data submitted to prove 
the safety of Captan, and additional data were requested, but the 
record indicates that none were provided. The Schuth review further 
revealed that in 1969, "interim" Captan tolerances for five food com- 
modities had been granted for a period of 6 months on the condition 
that data needed to prove the safety of the tolerances would be pro- 
vided by January 1, 1970. However, the data was never provided, and 
the "interim" tolerances on pineapples, potatoes, beans, almond hulls, 
and almond nuts are still in force today, 6 years later. 133 

The third and final review performed by Ms. Schuth was on the 
Ferbam correspondence files, which was completed in mid-June 1976. 
Once again, it was shown that data, which had previously been ac- 
cepted in support of 64 Ferbam residue tolerances on food commodities, 
had also been criticized by FDA and EPA reviewers. 134 And, on April 14 
1976, guidance packages citing the questionable data as "sufficient" 
for reregistration had been mailed to manufacturers of 45 pesticide 
products containing Ferbam. 135 

High level personnel fail to take timely action 

By early June 1976, Edwin L. Johnson, Deputy Assistant Ad- 
ministrator, Office of Pesticide Programs, had been briefed verbally 
on the findings of the Schuth reviews, and, finally, in writing on 
June 28, 1976: 

A limited examination of the files already has indicated that 
FDA/EPA scientists in the past raised what appear to be serious 
questions about the adequacy of toxicological data; in the cases 
reviewed thus far, there is no record to indicate that these ques- 
tions ever were resolved. Reregistration is the appropriate mech- 
anism for dealing with them. No matter how the legislative history 
is read, EPA would be hard put to rationalize a decision to dis- 
regard information in its own files, particularly after recognizing 
that such information may in many cases raise questions as to 
whether reregistration should be issued. 136 

It was recommended to Mr. Johnson that an ''ad hoc group . . . 
be set up immediately" to review the correspondence files on "all 
other pesticides for which there are or were tolerances or exemptions 
from tolerance requirements/' and that a "concrete plan" for the 

Registration Ta^k Force to Consider the findings of the reviews "be 

prepared as soon as possible.' 1 137 



'« Note 60, supra. 

:. Attachment No. 2, "Review of the Tolerance Correspondence Files for Captain." See 
appendix. 

Train letter, supra. Attachment No. 3, "Review of the Tolerance Correspondence Files for 
Frrixim. Bee appendix. 

morandum dated June 28, l'JTO, from Irwin L. Auerbach, Ms. ( urter Schuth, and Bingham Kennedy 
to Bdwin L. Johnson, Deputy Assistant Administrator, Offlotof Pesticide Programs. 

>" Ibid. 



31 

In spite of the various problems, high level personnel in EPA ap- 
parently never demanded timely explanations from those most familiar 
with the programs' shortcomings. Mr. Quarles was not briefed 138 on 
the problems in the reregistration and tolerance setting programs until 
July 12, 1976, over a month after the inadequacies in these programs 
had become evident to the Office of Pesticide Programs, and 12 days 
following Chairman Kennedy's written request to Mr. Train for in- 
formation on the two programs. And, it was not until July 28, 1976, 
that the Office of Pesticide Programs briefed Mr. Train on the 
gross inadequacies of the safety testing data reviews in the reregis- 
tration program. 139 When Mr. Train finally did focus on these problems, 
the information he received was in many respects quite accurate. He 
was candidly informed that the original assumptions underpinning 
EPA's regulatory efforts in the pesticide area were simply invalid. 

EPA had assumed that pesticide safety testing had been properly 
performed, that test data had been reviewed according to current and 
valid scientific standards, and that even those problems with the data 
which had been identified by previous reviewers had been resolved 
or corrected. 

The facts, of course, were far different than the assumptions, and 
these facts were pointed out to Mr. Train in late July. 140 The problem, 
however, was that the facts were presented as something entirety 
new and surprising, when they had actually been known to the agency 
for quite some time. The 1969 Fountain report, the 1969 Mrak report, 
the Aldrin/Dieldrin and Chlordane/Heptachlor cases spanning from 
1971 to 1975, and the GAO report to the Congress in late 1975 could 
have left no doubt in anyone's mind that there were serious deficiencies 
with data EPA had relied upon to reregister pesticides and grant 
residue tolerances. And, since the Schuth reviews of the correspondence 
files had begun almost 4 months prior to the briefing of Mr. Train 
on July 28, 1976, and completed by mid-June 1976, it was hardly 
accurate on July 28 to characterize all this as "new developments." 

On July 28, 1976, Mr. Train also was told: 

Scientific and regulatory standards have changed substantially 
over the past 25 years. Not only are more tests required; in addi- 
tion, testing is expected to be more thorough and sophisticated. 
Techniques for detecting adverse effects have improved. Scientific 
thinking regarding interpretation of observed changes in test 
animals has changed. 141 
It is hard to understand how this obvious observation was not 
known to EPA at the time of its formation in 1970 [one year after the 
Fountain and Mrak reports], and in 1974 when the initial assumptions 
concerning the adequacy of data were made, or in January 1976 when 
Mr., Quarles testified before the subcommittee, or in April 1976 
when Mr. Train testified before the subcommittee. 

Failure to commit adequate or appropriate resources to correct problems 

Finally, on July 28, what EPA proposed to do about all this had in 

fact been recommended, but not acted upon, nearly a month earlier. 

1 38 Memorandum dated July 9, 1976, from Irwin L. Auerbach, Chairman, Working Group on Pesticide 
Testing, to Edwin L. Johnson, Deputy Assistant Administrator, Office of Pesticide Programs. 
138 Paper entitled "Briefing for the Administrator," July 28, 1976, Office of Pesticide Programs, E PA. 
•«> Ibid, 
m Note 139, supra. 



32 

An "ad hoc" ^ronp, consisting of six Registration Division personnel, 
was told to examine correspondence files on additional pesticides — to 
pick up where Ms. Schuth left off in mid-June 1976. However, the 
group was plagued with serious difficulties from the very start. At 
least two of the reviewers, an entomologist and a plant pathologist, 
did not have sufficient expertise to determine whether prior reviewers 
had dealt adequately with deficiencies in human safety testing data. 
Moreover, the group also was seriously hampered by the data files 
themselves, which were, and still are, incomplete and disorganized. 
Yet, in spite of the many obstacles confronting the "ad hoc" group 
during its 2 months of work, it did discover deficiencies and question- 
able decisions in prior reviews of safety testing data similar to those 
which had been revealed in the Schuth reports 3 months earlier. 

Tfte reregistration program collapses and EPA concedes 

Finally, on August 9, 1976, the reregistration program was halted 112 
for the second time in 8 months. The collapse of the program came 
after 72 reregistration guidance packages, covering 2,527 pesticide 
products, had been mailed to manufacturers without the safety 
testing data, cited in the packages as "sufficient" for reregistration, 
having been adequately validated. 

In early August, personnel were assigned to formulate revisions in 
the reregistration program, and shortly thereafter put forth a number 
of recommendations, including: (1) the compilation of a "chemical 
review file" for each pesticide chemical, which would include such 
new information as summaries of prior reviews, use history, inputs 
from other sources (outside the agency), and the compiler's observa- 
tions, notes, and comments; and (2) the creation of a chemical review 
file "review panel," which would pass on the adequacy of all of the 
data and information collected. 143 This proposal was approved by 
those responsible for the program. 144 

On August 20, 1976, in a letter to Chairman Kennedy, Mr. Train. 
citing "recent developments," confessed that the "assumptions" under 
which the program had been conducted were "questionable," and stated : 

We have, therefore, determined that prior reviews of toxicological 
data must be examined and assessed as an integral part of the 
reregistration process. ... It is expected that a detailed plan 
will be completed early next month. lM [Emphasis added.] 

Mr. Train further stated: 

We have not yet Undertaken a systematic review of the 
tolerance petition files to determine whether to suspend or modify 
existing tolerance-. A thorough review in this area is needed and 
will be undertaken after the reregistration process is finished. 1 * 6 
[Emphasis added.] 



i«* Memorandum dated Augusl 9. L976, from Douglas i>. Campt, Associate Director, Registration 1 >i vi- 
sion. OiM', to Produd Bi Uting Chief. Producl Control Branch, Registration Division. 

'« Memorandum dated Augusl 10, 1976, fn D < ixnpt, Associate Director, Registration Divi- 

sion, OPP, l>r. William Wells, Chief, Standards and Labeling Section, Registration Division, Ol'l', and 

Million Division, OPP, to John li. Hitch, 
Director, Registration Division, OPP. 

i«* Memorandum dated Augusl L8, 1976, from Edwin D Johnson, Deputy Assistant Administrator, OPP, 
to John b. Rltch, Director, Registration Division, OP P. 

•«* Note 20, supra. 

H*NoJ 



33 

However, the "detailed plan" referred to by Air. Train, and pre- 
sented to Mr. Quarles on September 3, 1976, projected that, with a 
work force increased from 23 to 56 personnel, reregistration would 
not be completed until July 1979. 147 This would have meant that a 
"systematic review" of residue tolerances would be delayed for an 
additional 3 years. Yet, in September 1975, EPA had promised GAO 
that it would begin a "reassessment of tolerances." 148 

Tolerance-setting program also deficient 

Although the subcommittee concentrated its inquiry on the re- 
registration program, it appears that the same problems that have 
plagued reregistration also plague EPA's tolerance-setting program. 
The setting of tolerances for pesticide residues in and on foods and 
feeds is, of course, an EPA responsibility as vital as reregistration, 
and faults in the former have potentially disastrous implications for 
human health. Yet, as of September 1976, EPA proposed not to begin 
performing a "systematic review" of the more than 4,000 existing 
residue tolerances until 1979. 

The tolerance-setting program, like reregistration, appears to 
receive EPA attention only when it is criticized and questioned by 
outside parties. In 1975, for example, the GAO's criticism of EPA's 
tolerance-setting procedure did lead to the drafting of an EPA paper 
in late 1975 on the "United States Pesticide Tolerance System." 149 
The paper was an attempt to describe in detail the standards and 
criteria for setting pesticide residue tolerances in and on foods and 
feeds, something which had never been done in the history of the 
agency. However, this important task was given very low priority, 
and has yet to be completed. One of the authors of the first draft of the 
paper wrote later: 

Further development of the manuscript will be given low 
priority unless you believe the additional effort is worth the 
candle. The protracted clearances through OGC [Office of 
General Counsel], FDA and USD A and the delay in publication 
might cause the paper to be obsolete anyway. 150 

It was not until the summer of 1976, 8 months later, that work on the 
paper was resumed, and it is not expected to be completed until early 
January 1977. 

After repeated inquiries from subcommittee staff this fall, the Office 
of Pesticide Programs has promised to perform a limited review of 
tolerances beginning on January 1, 1977, in conjunction with the 
reregistration program. EPA hopes to commence a systematic review 
of previously set tolerances by the beginning of 1978, after completing 
an assessment of the scientific basis for establishing tolerances. 

i« Paper entitled "Briefing Agenda— Sept. 3, 1976," Office of Pesticide Programs, EPA. 

i« Note 21, supra. 

M » Paper entitled "United States Pesticide Tolerance System," November 11, 1975, by Dr. Orville E. 
Paynter, Joseph Q. Cummings, and Dr. Martin H. Rogoff, Registration Division, EPA. 

180 Memorandum dated December 18, 1976, from Dr. Orville E. Paynter, Chief, Toxicology Branch, 
Registration Division, OPP, to Dr. Martin H. Rogoff, Pesticides Science Officer, Registration Division, 
OPP, and Joseph G. Cummings, Chiof, Chemistry Branch, Registration Division, OPP. 



34 



CONCLUSIONS 



EPA failed to recognize and respond to early and repeated warnings 
that the data it was relying upon were faulty and incomplete. As a 
result, EPA went ahead and approved as "sufficient" data for reregis- 
tration of numerous pesticide products — data which may not only 
prove to be insufficient, but may also prove the products to be unsafe. 
Moreover, EPA failed to consider previous critiques of safety testing 
data in its own files, and in most instances failed to even read the 
critiques. Top-level agency personnel dragged their feet in responding 
to these problems as they became known, and the meager responses 
to correct the problems have been too little too late. 

The reregistration program's deficiencies also infect the tolerance- 
setting program. The net effect of these deficiencies is the probability 
that many of these pesticide products now on the market would be 
found to be unsafe if EPA regulated pesticides the way it is required 
to under the law. 

EPA's failure to validate testing data for purposes of reregistering 
pesticides has caused needless and costly delay in determining to w T hat 
extent pesticides currently on the market cause such adverse effects as 
cancer, birth defects and interference with biological reproduction. 
This delay has potentially prolonged the widespread use of some 
poisons dangerous to health and the environment, and w r ill result in 
unnecessarily raising the costs of compliance for pesticide manu- 
factures. 

Despite its promise to GAO in September 1975, EPA has yet to 
begin a review of the more than 4,000 pesticide residue tolerances 
previously set in and on foods and feeds, and therefore has prolonged 
the exposure of humans, animals, and the environment to pesticide 
residues which may be harmful. 



IV. LEPTOPHOS: A CASE HISTORY ILLUSTRATING THE 
SEVERE INADEQUACIES AND DEFICIENCIES IN EPA'S 
TOLERANCE-SETTING PROGRAM 

The problems plaguing EPA's tolerance-setting program and their 
implications for human health can be illustrated by examining the 
case of the pesticide Leptophos. Leptophos or Phosvel, as it is also 
called, is one of some 300 pesticide chemicals for which EPA has set 
tolerances for residues in and on food and feed commodities consumed 
in the United States. The superficiality of EPA's scientific review in 
granting tolerances for Leptophos is quite typical of its entire program. 
Whether the health dangers of Leptophos are also typical of other 
pesticides for which tolerances are in effect is impossible to determine 
unless EPA undertakes a systematic review of previously granted 
tolerances on other pesticides. 

Granting oj tolerances 

In 1973 and 1974, while EPA was evaluating the Leptophos safety 
testing data submitted by Velsicol, EPA received repeated warnings 
from scientists, within and outside the agency, that Leptophos was 
neurotoxic in mammals and fowl. These warnings were based on 
studies and data not included in Velsicol's data submissions to EPA. 

These warnings included : 

1. A letter from a World Health Organization scientist, dated 
November 19, 1971, stated: 

[E] valuation for neurotoxicity was carried out and this com- 
pound [Leptophos] was shown to give neurotoxic effects in 
hens. . . . 

On the basis of this data this compound should not be used in 
vector control work, and therefore further evaluation in the 
WHO Program should not be carried out; 151 

2. Results of an experiment conducted in 1973 at an EPA labora- 
tory, in which adult hens were injected with Leptophos, indicated that 
the pesticide was capable of inducing the delayed neurotoxic symptoms 
of leg weakness and paralysis; 152 

3. A scientific article describing an experiment performed in 1973 at 
Alexandria University in Egypt, in which roosters were fed Leptophos, 
concluded : 

[T]he present results clearly demonstrate that Leptophos 
causes delayed neurotoxic effects when administered orally to 
male chickens. Since it is assumed that a compound showing 



151 Letter dated November 19, 1971, from A. R. Stiles, scientist (chemist-biochemist \ vector biology and 
control, World Health Organization, to Dr. R. L. Met calf. 

152 Memorandum dated July 13, 1*»73, from Dr. Ronald L, Baron, Primate and Pesticide Effects Labora- 
tory, Perrine, Fla., EPA, to Dr. Clara Williams, Chief, Toxicology Branch, Registration Division, OPP, 
EPA. 

(35) 



36 

such activity might produce the same effect in man, Leptophos 
requires careful consideration before it is allowed to be freely 
used; 153 

4. On April 8, 1974, at a conference arranged and attended by 
EPA scientists, Dr. Wendell Kilgore, Chairman, Toxicology Depart- 
ment, University of California-Davis, revealed that Leptophos had 
presumably resulted in the accidental fatal poisoning of some 1,200 
to 1,300 water buffalo in Egypt in 1971 or 1972. Dr. Kilgore also 
reported that symptoms of paralysis, similar to those observed in 
the accidental poisoning episode, were produced in an experiment 
performed by the Egyptian Government in which Leptophos was 
fed to small groups of water buffalo; 154 

5. On April 12, 1974, EPA scientists met with Dr. Abdel-Moneim 
Makky, Egyptian Ministry of Health, who confirmed through first- 
hand knowledge what Dr. Kilgore had related to EPA on April 8, 
1974 ; 155 and, 

6. A letter dated April 30, 1974, from Dr. Robert L. Metcalf, 
Professor, Department of Entomology, University of Illinois, to an 
EPA scientist stated: 

At a recent pesticide meeting in Bellagio, Italy . . . Dr. 

John Barnes, Chief Toxicologist, WHO, indicated publicly 

that his original tests on Leptophos showed clearly that it was 

neurotoxic a number of years ago. 156 

Yet, EPA chose to di>count all of this evidence, including its own 

study conducted in 1973, which seriously undermined Velsicol's 

claims that Leptophos was safe. Instead, EPA chose to credit and 

rely upon reports developed for and submitted by Velsicol — all of 

which concluded that Leptophos was safe. And, on May 31, 1974, 

EPA granted tolerances for Leptophos in and on tomatoes and lettuce. 

Decision to seek revocation of tolerances 

The next step would have been for EPA to register Leptophos 
products for u-e on those two commodities in the U.S. However, 
the controversy over Leptophos persisted inside and outside EPA. 
On July 30, 1974, 2 mouths after EPA had granted the tolerances, 
the agency finally concluded that there was a need to reevaluate 
all available safety testing data pertaining to Leptophos. 1 * 1 This 
revaluation consisted of performing analyses which KPA bad never 
bothered to perform in the Brs1 place before granting the tolerances. 
It revealed that an early test [M submitted to EPA by Velsicol and 
relied upon to award the tolerances did in fact show evidence of 

'••"Neurotoxic Effect of Leptophos." by M. B. A.bou-Donla, et el., Dei 
College of Agriculture, Alexandria University, Alexandrl May 21, 1978, Expertentia 50, 81, 1874, 

oorandum for the file dated April 25, 1974, from Dr. Ounter Zwetg, chief, < bemistry Branch, 
i Evaluation I >i i lion, OPP. 
«• Memorandum for the file d 1974, Dr. Ountei Zwelg, Chief, Chemistry Branch, Criteria 

and Evaluation Division, OPP. 

■••Letter dated April 30, 1974, from Dr. Robert T,. Metcalf, Professor, Department of Entomology, 
University of niin<iis ;it Drbei • t, to Dr. Donna . Office of Research and 

Development, Ki'A. 

wr Memorandum dated July 80, 1974, 1 roxicology B 'ration 

Division, ope, to I Ide Science OPP. 

Ion Stuav elm kens, IBT No. J7162, from Industrial Blo-Teel Labor 
Inc., Northbrnok, ill., to Velsicol Chemical Corporation, Jul 



37 

neurotoxicity. 159 Moreover, a repetition of the test clearly showed 
that Leptophos produced delayed neurotoxic effects. 160 In addition, 
a new look 161 at EPA's own test conducted in 1973 confirmed what 
had already been stated by an EPA scientist in 1973 — that Leptophos 
"is capable of inducing a dela}^ed neurotoxic effect." 162 EPA's re- 
evaluation also elicited scientific opinions from Europe that Leptophos 
was so toxic that it would never be registered there for use on food. 163 
In May 1975, a year after the tolerances had been approved, 
EPA finally decided to act upon the results of its reevaluation, and 
proposed to revoke the Leptophos tolerances. 164 

Velsicol opposes revocation in spite of evidence oj harmful effects 

Velsicol vigorously opposed EPA's proposed revocation of the 
Leptophos tolerances. In a letter dated June 24, 1975, to EPA, the 
company argued that the tolerances had been properly granted, and 
invoked a provision of the Federal Food, Drug and Cosmetic Act 
which required EPA to form a scientific advisor committee to con- 
sider the proposed revocation. 165 However, before sending this letter, 
Velsicol had received the following information from its medical 
consultant on June 9, 1975: 

As you know, it has recently come to our attention that there 
have been a series of unusual central nervous s3 T stem illnesses 
occurring amongst the employees of (the Bayport, Texas, plant 
which manufactures Leptophos). Apparently most of the illnesses 
occurred among those who were in contact with [Leptophos]. 
[One of the workers], who was employed . . . for approximately 
4 months in the late winter and early spring of 1974, . . . began 
to develop a series of bizarre central nervous system symptoms 
which was followed by his being hospitalized . . . with the 
diagnosis of encephalomyelitis for 8 months. At that time the 
patient was severely ill, almost died, and was then left with a 
number of serious residual nervous system deficits. In addition, 
there have been at least two individuals employed in this shop 
who had a diagnosis of multiple sclerosis, another with a history 
of seizures and hallucinations, and fairly recently still another with 
a diagnosis of encephalitis. ... I advise that the company 
seriously consider halting the manufacture of [Leptophos] until 
these matters are clarified. 166 

189 Note 158, supra. The report concluded that examination of tissue from chickens fed Leptophos "did 
not reveal any evidence of demyelination [nerve damage] in any of the chickens tested." However, the body 
of the report included numerous descriptions of such neurotoxic symptoms as: "no control of legs;" "very 
unsteady;" "cannot remain standing;" and "extreme staggering." 

Following a review of the tissue slides in mid-August, 1974, Dr. Howard Eichardson, an EPA pathologist 
concluded in a memorandum, to "The Record", dated August 27, 1974: "The [tissue] sections of the nerves 
wer^ highly questionable and unreadable. . . . In . . . my opinion these [tissue] slides have been impossible 
to evaluate from the time they were prepared." 

"° Memorandum dated November 15, 1974, from Dr. Howard L. Richardson, Chief of Pathology, Office of 
Pestipide Programs, EPA, to Henry J. Korp, Deputy Assistant Administrator, OPP. 

161 Memorandum dated August 19, 1974, from Dr. Kent Davis, Pathologist, Registration Division, OPP, 
to Dr. Clara H. Williams, Chief, Toxicology Branch, Registration Division, OPP. 

"2 Note 152, supra. 

183 Memorandum, undated, European itinerary of Howard L. Richardson, M.D., and Mary B. Richard- 
son, M.D.. September 4, thru October 9, 1975. 

184 Leptophos, proposed revocation of tolerance, 40 F.R. 22817, May 27. 1975. 

168 Letter dated June 24, 1975, from Ralph F. Anderson, Vice President, Research, Velsicol Chemical 
Corp., to the Administrator, EPA. 

J« Letter dated June 9, 1975, from John E. Kasik, M.D., Consultant, Velsicol Chemical Corp., to Charles 
Calo, Manager, Toxicology Research, Velsicol Chemical Corp. 



38 

Moreover, a report 167 to Velsicol, dated June 20, 1975, from the 
same medical consultant described the illnesses of a dozen employees 
who had suffered such symptoms as: paralysis (in at least three cases), 
impotence, confusion, lethargy, severe ataxia (lack of coordination), 
weakness, sweating, difficulty in swallowing, and vomiting. One of the 
workers, employed at the plant from January 10, 1974, to May 2S, 
1974, was able to walk only "with the assistance of double leg braces 
and walking canes," following hospitalization. Another employee, who 
had worked at the plant for 3 months, until May 13, 1975, was hos- 
pitalized in critical condition on May 14, 1975. According to the 
report, as of mid-June 1975, the employee was still not able to walk. 
The report concluded: 

I think the preponderance of the evidence is that all the cases 

had the same type of illness, either acutely or chronically, and the 

etiolocry was related to their job and their contact with 

[Leptophos]. 16S 

The medical consultant's report, among other things, recommended 

that: 

... at this time a discrete investigation be made of all the 

employees who have been in contact with [Leptophos], but who 

are no longer employed at Ba} T port, be made. ... I would 

also recommend that at this time a regular survey of the health 

of all the employees of Velsicol engaged in the manufacturing of 

pesticides be made. 169 

However, neither the report nor the information supplied by the 

medical consultant was included or referred to in Velsicol's letter of 

June 24, 1975, challenging EPA's proposal to revoke the Leptophos 

tolerances. In addition, Velsicol continued to manufacture and 

market Leptophos for use outside the United States — on foods that 

were subsequently consumed within the U.S. The company did, 

however, begin to take some steps to reduce the exposure of its 

employees to Leptophos at its Bayport plant. 

In October 1975, a second medical consultant recommended that 
Velsicol "begin a search for all previous exposures," and either . . . 
stop production of the material or store it until [Velsicol] can better 
determine complete implication of its use." 17 ° But not until Novem- 
ber 19, 1975, 171 5 months after it had received the report from the 
first medical consultant, did Velsicol inform EPA of illnesses suffered 
by some employees "which may have been related to Leptophos 
exposure." 172 Moreover, neurological examination of the plant's 

iw Report date] Juno 20, 1075, from J. E. Kasik, M.D., Ph. D., Consultant, Velsicol Chemical Corp., to 
Charles Calo, niical Corp. 

■« Note 187, supra. 

1» No: 

tter dated Oct. 21, 1975, from Q. O. Alexander, M.D., Consultant to Velsicol Chemical Corp., to 
N<*il H. Mitchell, General Counsel, Velsicol Chemical Corp. 

1 7 ' Letter dated November 19, 1976. from Neil R. Mitchell, Vice President— Legal, Velsicol Chemical Corp., 
to Franklin D. R. Gee, (Product Manager for Leptophos) Insecticide Fungicide Hraneh, Registration Di- 
vision. EPA. 

The letter stated: "Velsicol has instituted a program of complete Dearological examinations for all cunent 
plant workers <in November 1975). . . . Should the examinations reveal a true pattern of illness related to 
ex[K>sure to Leptophof m the packaging-warehouse area, effi rta to locate end examine all former workers in 
.it area will lie initiated. Velsicol will also review the situation with those domestic companies that 
: tnuiated Leptophos for export. . . . 
Velsicol Intends to submit to EPA the full rnedieel report and as analysis of Leptophos exposure levels as 
soon as they are completed SS purl of the record for the 1 EPA) advisory committee." 
»" Ibid. 



39 

current employees was not begun until November 1975, 173 and pro- 
duction of Leptophos was not halted until January 1976, 174 shortly 
after inspectors from the National Institute for Occupational Safety 
and Health (NIOSH) had made known to Velsicol their intentions to 
inspect the plant in February. 175 

Velsicol received preliminary results in the spring of 1976 on the 
neurological examinations of its workers who were employed at the 
Leptophos plant when the examinations were begun in November 

1975. The preliminary findings showed that at least two of the workers 
had suffered from neurotoxic effects. One of the cases involved a 26 
year old worker who, after 2 years of working at the Leptophos plant, 
suffered from drowsiness, numbness from the waist down, and unknown 
prospects for recovery. 176 This information prompted a third recom- 
mendation to Velsicol, this time from a NIOSH medical officer in 
May 1976, that former workers, who had been employed at the 
Leptophos plant prior to the beginning of the neurological examinations 
in November 1975, also be checked for health status. 177 This recom- 
mendation was ignored. 

Advisory committee was not given full facts in a timely fashion 

Meanwhile, the Leptophos advisory committee, 178 which was em- 
paneled to review EPA's proposed revocation of the Leptophos 
tolerances on lettuce and tomatoes, held its first hearings on July 20, 

1976. Although EPA, weeks prior to the hearings, had sent to the com- 
mittee members a substantial amount of data and documents pertain- 
ing to Leptophos, the agency personnel had failed to include the Velsicol 
submission 179 of November 19, 1975 describing the illnesses suffered by 
some employees. That same submission stated that Velsicol intended 
"to submit to EPA the full medical report and an analysis of Leptophos 
exposure levels as soon as they (were) completed as part of the record 
for the [Leptophos] advisory committee. " 1S0 

During the first day of hearings on July 20, 1976, both EPA and 
Velsicol representatives spent considerable time outlining the regu- 
lator}^ and use history of Leptophos, and the safety testing of the 
pesticide utilizing animals. EPA confessed to the committee that the 
safety testing data "had not been adequately considered" prior to 
the agency's granting of the tolerances in 1974. 1S1 However, in con- 
nection with information on exposure of Velsicol's employees to 

w Report dated April 2, 1976, by H. L. Markel, Jr., P. E., C.S.P., regional industrial hygienist, National 
Institute of Occupational Safety and Health, HEW. 

»" Ibid. 

» r « Ibid. 

17 « Memorandum dated May 26, 1976, from Shiro Tanaka, M.D., Medical Officer, Medical Section, Hazard 
Evaluations and Technical Assistance Branch, National Institute of Occupational Safety and Health, 
HEW, to the Director, Division of Surveillance and Hazard Evaluations and Field Studies, NIOSH, HEW. 

in Note, 166, supra. 

l7j Julius M. Coon, Ph.D., M.D., Chairman, Leptophos advisory committee, emeritus professor of phar- 
macology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pa.; Seymour L. Friess. 
Ph.D., Chairman, Environmental Biosciences Department, Naval Medical Research Institute, Bethesda, 
Md.; Tetsuo R. Fukuto, Ph.D., Professor of Entomology, Chemistry, and Insect Toxicology, Department 
of Entomology, University of California, Riverside, Cal.; Bernard P. McNamara, Ph.D., Chief, Toxicology 
Division, Biomedicals Laboratory, U.S. Army Material Command, Edgewood Arsenal, Md.; and Gerald 
M. Rosen, Ph.D., Assistant Professor of Pharmacology, Department of Physiology and Pharmacology, 
Duke University Medical Center, Durham, N.C 

»• Note 171, supra; 

»° Note 171, supra. 

lSl Testimony of Dr. William Upholt, Senior Science Adviser to the Assistant Administrator for Water 
and Hazardous Materials, EPA, before the Leptophos Advisory Committee (empaneled by EPA), Julv 20, 
1976. 



40 

Leptophos, some of which was more than a year old, company officials 
volunteered very little to the committee. Velsicol's representatives 
minimized the degree of their knowledge in testifying before the 
advisory committee. According to a draft of a prepared statement 182 
for the committee, the company's "fullest" statement volunteered to 
the committee on the dangers Velsicol had known about for over a 
year was as follows : 

We have noted certain cases, still unresolved, which, if related 
to Leptophos, may have been the result of inadvertent exposure 
to high levels of technical material. A report is in preparation 
which deals with our domestic manufacturing experience and 
will be made available to the Committee and EPA bv August 20, 
1976. 183 
Neither the company officials nor EPA personnel at the July 1976 
hearings mentioned, much less produced, the November 19, 1975, 
submission by Velsicol which gave some detail on "a variety of ill- 
nesses" suffered by workers at the Leptophos plant. 184 Moreover, 
both EPA and the company failed to reveal to the committee at the 
July hearings that medical officers from the National Institute for 
Occupational Safety and Health had inspected the Leptophos plant 
in February 1976, and had preliminarily found that "at least five (5) 
employees were listed as possible chemical exposures," and that 
''several previous employees (were) reported to have filed a Texas 
Workmen's Compensation claim for their illnesses." 185 On July 21, 
1976, when the advisory committee requested that Velsicol submit 
as soon as possible whatever "rough data" the company possessed 
relating to the effects of Leptophos on humans, a Velsicol representa- 
tive stated that he did not know what was available. lMi 

Nearly a month after the advisory committee hearings, Velsicol 
withdrew 187 it.^ applications i\)i- registration of the company's Leptophos 
pesticide products and on the same day, August 17, 1976, Velsicol 
submitted to EPA the documents Kss (some of wiiich dated back more 

• actual statement delivered to the advisory commftti d >ng with the reporter's tape of 
Velsicol's testimony before the eommlttee. 

i«o : - : rtth Leptophos Science A raunlttee," Velsicol Chemical Corpo- 

ration. July 20. 1976. 

> Si Note 17), supra. 
■ \7'A, supra. 

»x Testimony of Charles Calo, Velsicol Chemical Corp., before the Leptophos Ad miittee 

(empaneled by EPA), July 21, 1976. 

tarda ad locust 17. 1976, from Thon aa R. Loy, Manager, Regulatory Activities, Research De- 
partment Velsicol < 'in D. R. (lee, Product Manager 16, Insecticide-Rodenticide 
Branch, Registration Division, Environmental Protection Agency. 

1 ' 8 The documents Included: 

• ter dated June 9, 1976, from John E. K:wk, M. D., Consultant, Velsli (.1 ('hemic:'.! Corp.. to Charles 

er, Tozicolofl ( Velsicc) Chemical Corp.; (2) Report dated June 20, 1975, from J. E. 

'. M. I)., I'h. i).. Consultant, Velsicol Chemical Corp.. to Charles Calo, Vel icol Chemical Corp.; 

(3) InU ■ munlcation dated June 15, 1975, fro i (Vel in. I Chemical Corp.) to Larry 

Goodwin (Vel Icol Chemical Corp.): i-n Letter dated October 24, 1975, from I aider, M. lb. 

(Medical Consultant to Velsicol), to Nell R.Mitchell, Genera] Couns< I, \ elsi< oi Chemi Letter 

November 12, 1975, from <;. G. Alexander, M. lb. (Medical Consultant to Veil liam s. 

Lrtment of Neurology, University of Texas, Collegi Rous ton; 

lovember 12, 1975, from i ider, M. D. (Medical Consultant to Velsicol), to 

Law, Velsicol Chemical Company; (7) U tti i dati d Novi 

from <;. <;. Alexander, M. D. (Medical Consultant to Velsicol). to Nell R. Mitchell. Attorney al Law, 

A Lexander, \i. D. I Medical Con- 
sultant to Vel Icol). to Jim A. Mack it. Velsicol Chemical (dip.: (9) Letter dated JuU :".'. 1976, from Q. G. 
der, M. I). (Medical Consultant to Velsicol), to NT.il Mitchell, Vice President, Legal l>< part merit. 
mical Corp.; (10) Industrial Hygiene Survi Phosvel (Lentophi 

for Velsicol Chemical Corporation by Stephen R. Levltan, I'd. i>.. Environmental Labs/Diamond Sham- 

. inspection oi the \ ci [col Chemical Corp. Leptophos manu* 
nt in Bayport I M el, Jr., P. !•'.. C. 8. P., Regional Industrial Hyi 

MIOSH, \\ (medical \a if Velsicol Chemical Corp. 

dating from December 22, 1971, to May 25, I port dated August 12, 1976, "Technical Leptophos 

\ i Uc< l chemical Corp. to the Environmental ; Lgencs ; 

and (14) "Draft" (Report), "velsicol chemical Corp., Phosvel (Leptophos) Manufacturing, Bayport, 

bine 1976. 



41 

than a .year) relating to exposure of Velsicol employees to Leptophos. 
The next day Velsicol wrote the advisory committee saying that it 
had withdrawn its registration application: 

Under the circumstances, Velsicol feels that it must hereby 

withdraw its request for the Advisory Committee appointed to 

consider Leptophos tolerances. 189 

Enclosed with the letter were the same documents 19 ° supplied to 

EPA on August 17, 1976, relating to the exposure of workers to 

Leptophos, and certain other documents requested by the committee. 

Despite Velsicol's decision to "withdraw its request," the Advisory 

Committee publicly released its report on Leptophos, noting that: 

There are indications that neurological effects have occurred, in 
workers involved in the manufacturing, packaging and application 
of Leptophos. m 
The committee recommended that "the currently existing tolerances 
(on lettuce and tomatoes) should be revoked," and that "additional 
toxicity data should be obtained before new tolerances are estab- 
lished." 192 EPA adopted the recommendations and published a 
notice 193 in the Federal Register on November 22, 1976, to revoke the 
Leptophos tolerances. 

Velsicol delayed implementing recommendations to examine ex-employees 
Although it had been recommended to Velsicol by a medical con- 
sultant in June of 1975, by XIOSH in May 1976, and by Dr. G. G. 
Alexander, a second medical consultant to the company, in October 
1975, that Velsicol check the health of former employees who were 
exposed to Leptophos, Dr. Alexander wrote to the companv on 
July 29, 1976, and stated: 

... I see no additional benefit to the people who have been 

in your employ by your making an active attempt to identify 

toxicity of your products to them. 194 

It was only very recently that Velsicol decided after all to check 

the health of its former employees. In fact, the decision to do so was 

communicated to the National Institute for Occupational Safety and 

Health on November 22, 1976, 195 3 days after the subcommittee staff 

had asked legal counsel for Velsicol why such a project had not yet been 

undertaken. Subsequently, on December 1, 1976, NIOSH stated that 

it intends to conduct its own medical survey of former employees of 

VelsicoPs Leptophos plant. 

Leptophos has been consumed in the United States 

As a final note, it is important to point out that, while Leptophos 
was never registered by EPA for use on tomatoes and lettuce crops 
in the United States, the agency's issuance of the residue tolerances 

»' Letter dated August 18, 1076, from Ralph F. Anderson, Vice President— Research, Velsicol Chemical 
Corp., to David Bowen, Secretariat, Leptophos Scientific Advisory Committee, Environmental Protection 
Agency. 

>»°Note 188, supra. 

191 The Report of The Leptophos Advisory Committee to the Administrator, U.S. Environmental Pro- 
tection Agencv, October P)76. 

>»2 Ibid. 

'" Repeal of Tolerance for the Pesticide Chemical Leptophos, 41 F. R. 51400, November 22, 1976. 

m* Letter dated July 2a, 1978, from G. (i. Alexander, M.D. (Medical Consultant to Velsicol), to Neil 
Mitchell, Vice President, Legal Department, Velsicol Chemical Corp. 

1J s Memorandum dated Nov. 22, 1976, from John F. Finklea, M.i>., Director, National Institute for Oc- 
cupational Safety and Health, to "The Record." 



42 

in 1974 did permit the import of these Le ptophos-tTea.ted commodities 
into the United States from other countries. 

In the case of Mexico, from which the United States imported 
62-i-million pounds of tomatoes this year alone, not only have Amer- 
ican consumers been eating Leptophos-contRminsited tomatoes from 
that country since 1972, but also Leptophos-coiito.mma.ted beans, 
peppers, cucumbers, peas, cantaloupe, egg plant and squash, for 
which tolerances have never been granted by EPA. 193 It is impossible 
to determine to what extent the various commodities imported from 
Mexico have been contaminated with Leptophos, since, according to 
FDA, some 35,668 shipments of agricultural commodities crossed 
the border into the U.S. during the last Mexican growing season alone, 
from October 1, 1975, through August 1, 1976. And FDA, which is 
responsible for monitoring pesticide residues on such imports, was 
able to sample only 650 of the shipments this year, and 265 shipments 
(excluding strawberries) in 1975. 

The Mexican Government states that the use of Leptophos on food 
crops was banned in that country in April of this year. However, 
according to Velsicol, Leptophos was sold to 29 countries 19: around the 
world in 1976, and since 1971, to 50 countries 198 at one time or 
another, which raises the possibility that the U.S. may still be import- 
ing Leptophos-contaminated foodstuffs from other countries. 

CONCLUSIONS 

EPA's approval in 1974 of residue tolerances for Leptophos in and 
on lettuce and tomatoes did much to encourage the use of the pesti- 
cide in other countries, such as Mexico and Egypt, since much of the 
world looks to the United States as the leader in science. 

EPA's issuance of the tolerances for Leptophos admittedly without 
having adequately evaluated the safety testing data was unjustified, 
and s< is a clear example of the agency's superficial treatment of 

such critical data. The result is that American consumers, as well as 
consumers of other nations, have been exposed to a demonstrably 
hazardous material. 

m Report, "FDA Findings of Leptophos Residues in Food," prepared by Bureau of Foods, FDA, Dec. 8, 

1,7 Surnniar. of Phosvel (Leptophos'* Shipped In Export, Provided by Harvey Cold, Velsicol Chemical 
Corp., Deo. 13, 1976. Countries to which Ve&co] ptophoa In 1976 are: Argentina. British Wesl 

Indies. Canada, Columbia, Costa Rl -a. Dominican Republic, El Salvador, Ethiopia, French Wesl 

i, Honduras, India, Indonesia, Iran, Ivory Coast, Japan, M ICO, Niw Zea- 

land, N Spain, Sudan, Syria. Taiwan. Thailand, and Venezuela. 

''-•Note 187, supra. Countries to which Velsicol has exported leptophos at one time or another sin--, p. 71 

Guiana, British W< i inada, China, Columbia, Costa 

rinican Republic, Egypt, El Salvador, Ethiopia, l ranee, French Weal Africa, • 
iiti. Holland, Honduras, India, Indonesia, ban. israi I, [vory ( 
. Lebanon, Mai: gua, Pakisl . Philippines, 

lldan, Syria, Taiwan, Thailand, Turkey, Union of South Afiiea, Venezuela. \ ■ 
and West Pakistan. 



V. MISLEADING STATEMENTS BY EPA 

The EPA has misled the Congress, the General Accounting Office, 
and the public regarding its pesticide programs. The EPA through 
public statements and other means fostered the impression that it 
was thoroughly reviewing all pesticide testing data submitted by the 
pesticide industry to determine whether the use of any of the 50,000 
pesticide products already on the market cause "unreasonable adverse 
effects" 199 on human health and on the environment. As demonstrated 
in section 2 of this report, the subcommittee's inquiry has revealed that 
EPA's "review" of data bearing on the question of safety over 2,500 
pesticide products as of August 9, 1976, was designed and executed 
in a superficial manner. "Review" and "validation" consisted in most 
instances of little more than the clerical function of checking for the 
presence of data in the Agency's files. Despite several indications 
that data submitted by the pesticide industry could not be relied upon 
without a thorough review and analysis, the EPA neglected to subject 
data to anything approaching scientific scrutiny. In fact, for purposes 
of reregistration the agency chose to ignore and failed even to read the 
comments of previous reviewers who had often criticized and ques- 
tioned the accuracy and completeness of the very same data that EPA 
was relying on to support reregistrations. Nevertheless, the EPA on 
many occasions gave the impression to those outside the agency that 
reregistration was being conducted in a thorough manner. The clear, 
foreseeable and natural consequences of these statements were to 
mislead the Congress, the General Accounting Office, and the public. 
The subcommittee's inquiry revealed the following examples: 
1. The General Accounting Office proposed report of July 18, 1975 
specifically criticized the fact that there were deficiencies in data sub- 
mitted to EPA to support registration and tolerances. 200 EPA's 
response to these criticisms was in the form of a memorandum under 
the signature of Edwin L. Johnson, Deputy Assistant Administrator 
for Pesticide Programs. In the September 1975 response, EPA made 
the following statements: 

[I]n preparation for reregistration, the data base supporting 
the safety of each registered active ingredient has been reviewed, 
and any gaps have been identified. 201 

If the data are not submitted, the registrations involved will 
kpse. If data are submitted, then the acceptance of the registra- 
tion will be judged on the basis of data. 202 

[W]e determined to concentrate resources in the area of highest 
priorit3 r , which is potential human hazard. A double standard 
was created in the regulations, limiting the scope of data require- 



»• Pub. L. 92-516, Oct. 21, 1972. 



200 Draft GAO report of July 18, 1975. Report to the Congress by the Comptroller General of the United 
States, dated Dec. 4, 1975, "Federal Pesticide Registration Program: Is It Protecting the Public and the 
Environment Adequately from Pesticide Hazards?" 

sol Ibid., 

202 Ibid., 

(43) 



44 

ments for reregist ration to safety data; including hazard to fish 
and birds, chronic mammalian effects, oncogenesis, terato 
genesis, and reproduction studies . . . 203 

(a) Before reregistration applications are solicited from the 
registrants, EPA reviews a group of products similar in chemistry 
and use. 

(b) 7%i8 review considers the sufficiency of supporting data . . , 204 
[Emphasis added.] 

2. EPA challenged GAO^s "finding" that "EPA has moved slowly 
to implement the reregist ration provisions of amended FIFRA, and 
thus will not meet the statutory deadline (initially set by the Congress 
as October 1976). 205 In his Saptember 11, 1975 response to the GAO 
report, Mr. Johnson stated: 

While the workload burden of reregistration is admittedly 

great, we are less certain than GAO that the statutory deadline 

of October 197G cannot be met, or at least closely approached. 206 

On October 7, 1976, a GAO auditor, assigned to the GAO audit 

team at EPA explained that GAO's finding that EPA could not 

meet the statutory deadline was based primarily on the premise 

that adequate review and validation of data submitted in support 

of reregistration could not be completed by October 1, 1976. He further 

explained that EPA never revealed that it was not validating the 

data. He stated: 

It was only recently, within the last 2 weeks, that we learned 
they weren't validating data. It's apparent now that all along 
all they intended to do was to check for the presence of data . . .. 
not doing a thorough review to see if the data was adequate. 207 

3. Mr. Russell E. Train, Administrator of EPA, testified before 
joint hearings on April 9, 1976 as follows: 

Senator Kennedy. What about the things that have been 
approved today that are out in the homes, that are all across 
this land, that are being used on various kinds of food products 
which are being ingested by the American people? How do we 
know what has been approved now by the EPA is really safe 
for the American people? 

Mr. Train. Obviously, you don't know. The fact is we are 
in the process of reregistering all 35,000-plus of those products 
at the present time, a process which we hope to conclude by 
I I itober 1977. 

Senator Kennedy. What does that mean to you when you, 
the person who has the responsibility, when von Bay you don't 

know how safe these are in terms of the American public? What 
does thai mean to yon? And what should that mean to the 
American people? 

Mr. TRAIN. It means to me we should do a very careful job 

of reregistration, of reviewing the data, and where there is any 

question about the data, and in many of these cases where we 
*i Ibid. 

*< n 

aded by Pub. L M-140 which amended deadline to Oct. 21, 1977. 

*• Not<- 21, supra. 

s* 7 Su . . Interview, Oct. l, l'.'76. 






45 

have already determined that in our view the original data is not 
fully adequate, we have already put parties on notice and will 
be including these in the rebuttable presumption (against regis- 
tration) approach that the manufacturers, the registrants, have to 
come in and carry the burden of proof of establishing safetv. . . . 
Pursuant to the 1972 amendments to the FIFRA, the" EPA 
is directed to undertake a reappraisal of pesticide products 
approved under the earlier FIFRA to determine if they meet a 
new statutory test that they will not have the "unreasonable 
adverse effects" to man and the environment. ... In conclusion 
Mr. Chairman, I believe that we at EPA have taken a number 
of steps which will ensure that the data received from pesticide 
manufacturers is of appropriate quality so that we can make 
the important regulatory decisions that are mandated by Fed- 
eral law. We view this as a vital function of our agency. 208 

4. In a letter to subcommittee staff, dated April 16, 1976, James M. 
Conlon, Associate Deputy Assistant Administrator for Pesticide 
Programs, stated: 

The ^registration process now underway, which Mr. Train 
described in his statement to the subcommittee last week, will 
provide an opportunity to reexamine the adequacy of the sup- 
porting data in EPA's files and, where necessar} r , to obtain 
additional data. 209 

5. The EPA was one of nine agencies examined over the past 2 
years by House Subcommittee on Oversight and Investigations, 
chaired by Representative John E. Moss. One of the primary focuses 
of that inquiry was the effectiveness of EPA's regulation of pesticides. 
Chairman Moss wrote a detailed letter to Mr. Train on June 9, 1976, 
requesting certain information regarding EPA's Office of Pesticide 
Programs. 

A. Question 2(h) posed to Mr. Train in that letter asked: 

The Office of Special Pesticide Review subjects candidates 
for rebuttable presumption to intensive chemical by chemical 
review of all data. . . . This intensive review is designed to 
verify the data that may support restriction on use or removal 
from the marketplace of a pesticide. Is there a comparable 
intensive review of all data advanced by registration applicants 
to support a determination to place a pesticide on the market 
(i.e. res^stration) or keep a pesticide on the market (i.e. reregistra- 
tion?) If not, why not? 210 
A working draft, dated June 29, 1976, of Mr. Train's reply to Chairman 
Moss' interrogatories was obtained by the subcommittee. 

The draft response to Chairman Moss's question contained the 
following statement: 

In short, data submitted in support of new [registrations] or 
continued registrations [reregistrations] are all reviewed com- 



2" « Testimony of Russell E. Train, Administrator, Environmental Protection Agency, before joint hear- 
ings by the Subcommittee on Health and the Subcommittee on Administrative Practice and Procedure, 
Apr. 9, 1976. 

209 Letter dated Apr. 16, 1976, from James M. Conlon, Associate Deputy Assistant Administrator for Pesti- 
cide Programs, EPA, to Jim Michie, Subcommittee on Administrative Practice and Procedure. 

- 10 Letter dated June 9, 1976, from John E. Moss, Chairman, Subcommittee on Oversight and Investk-a 
tions, House of Representatives, to Russell E. Train, Administrator, Environmental Protection Agency. 



46 

pletely to determine whether or not the product may pose un- 
reasonable risks. 211 
In a memorandum obtained by the staff dated June 30, 1976, 
Mr. Irwin L. Auerbach, program analyst, Office of Regulatory and 
Policy Affairs, Office of Pesticide Programs, commented on the work- 
ing draft's response to Chairman Moss' questions 2(h) as follows: 
Question 2(h): The statement that 'data submitted in support 
of new or continued registrations are all reviewed completely' 
is questionable. EPA's review for reregistration is cursory. It 
does not include an in-depth examination and evaluation of data 
previously submitted. Nor does it include any examination of the 
comments made by previous reviewers at the time that such 
data were submitted. 212 [Emphasis added.] 
After Auerbach's comments, the draft response was redrafted and 
incorporated in a letter from Mr. Train dated August 3, 1976. In spite 
of Auerbach's criticism of the draft response the final response of 
August 3 to question 2(h) which was submitted to chairman Moss 
on August 3, 1976 was substantially similar to the draft response and 
contained the following statement: 

In short, data submitted in support of new [registrations] 

or continued registrations [reregistrations] are all reviewed to 

determine whether or not the product may pose unreasonable 

adverse effects. 213 

Although Mr. Auerbach was Chairman of EPA's Working Group 

on Pesticide Testing, his comments were not included in the Agency's 

response to Chairman Moss' inquiry. 

Chairman Moss in his letter of June 9, 1976 posed another question 
to Mr. Train: 

On May 12, 1976, the Center for Continuing Education 
sponsored a seminar on the registration and regulation of pesti- 
cides at which Dr. Jay Turim, Deputy Director, Office of Regu- 
latory and Policy Affairs, Office of Pesticide Programs, Environ- 
mental Protection Agency . . . indicated that if 4 minutes were 
spent on each pesticide that must be registered by EPA, one man 
year would be consumed. What does this portend insofar as the 
quality of safety review the public can anticipate EPA will 
conduct on pesticides it registers is concerned? IM 
Responding to Chairman Moss' question 6(f), the working draft 
stated : 

The actual, physical review of any particular product's 
reregistration application may, in fact, he brief, as Dr. Turim 

indicated during the May 12, 1976, Center for Continuing 
Education seminar on the registration and regulation of pesti- 
cides. However, it is a serious error to consider this basically 

clerical task to represent the essence or entirety of the review 

procedure. The substantive work in assessing a pesticide's 

safety is done during the development of (lie guidance packages 



" I Jruft of EPA responses to questions of Chairman Moss, prepared by EPA personnel, dated June 29, 
1976. 

Memorandum dated June 80, 1976, from Irwin L. Anerbaeh, program analyst, OfTko of Retaliatory and 
Policy Affairs, OPP, to Susan Sherman, Chief, External AtTairs. OPP. 

i etter dated log. •'<, 1976, from RoaaU E. Train, Administrator, Environmental Protection /Lgency, to 
John E kirman, Subcommittee on Oversight and investigations, House of Representative!. 

»•« Note 210, supra. 



47 

for the various product groupings or batches based on similar 
formulation and broad use patterns. The guidance package 
includes proposed classification of the products in a batch, 
requisite wording of precautionary statements on labeling, 
acceptable statements on storage and disposal, and guidance 
on data requirements. This information cannot be provided 
without a thorough knowledge of the product's chemical charac- 
teristics, associated risks, uses, and probable sources of exposure. 
Guidance on data requirements is thus the result of an extensive 
review of data previously submitted to determine if they are 
sufficient and to identify data gaps which must be filled. Clearly, 
the guidance package is the product of considerable time and 
effort devoted in a systematic fashion to assessing pesticide 
safety. 215 

In his June 30 memorandum, Mr. Auerbach commented on the 
draft response as follows: 

. . . Question 6(f): The long paragraph on page 13 of the 
draft reply gives a misleading impression about reregistration. 
Preparation of guidance packages involves only cursory review oj 
scientific data in EPA 's files. See my comments on Question 2(h). 
Ed [Edwin L.] Johnson [Deputy Assistant Administrator for 
Pesticide Programs] is now aware that where more intensive 
reviews have been made, problems have been identified that were 
not noted by the Reregistration Task Force. I do not know how 
he would answer this question in light of these recent develop- 
ments. / do know that I would not answer it the way it's done in 
the draft. 216 [Emphasis added.] 

Nevertheless, EPA's final response to question 6(f), submitted to 
Chairman Moss on August 3, 1976, read as follows: 

The actual, physical review of any particular product's reregis- 
tration application may, in fact, be brief, as Dr. Turim indicated 
during the May 12, 1976, Center for Continuing Education 
seminar on the registration and regulation of pesticides. However, 
it is a serious error to consider this basically clerical task to repre- 
sent the essence or entirety of the review procedure. The sub- 
stantive work in assessing a pesticide's safety is done during the 
development of the guidance packages for the various product 
groupings or batches based on similar formulation and broad use 
patterns. The guidance package includes proposed classification 
of the products in a batch, requisite wording or precautionary 
statements on labeling, acceptable statements on storage and 
disposal, and guidance on data requirements. It is our intent 
' during the reregistration process to classify products, update 
labeling, identify data gaps, and review data on hand to the 
extent that we are assured that the problem pesticides will 
receive proper attention. We intend to revise our procedures 
when necessary as experience is gained during reregistration and 
difficult areas are identified. The average time spent on individual 
applications is thus irrelevant to the quality of the review and 
the commensurate public protection. 217 

*U Note 211, suora. 
2" Note 212, supra. 
2i7 Note 213, supra. 



48 

Here again, although Mr. Auerbach severely criticized the draft 
response, and characterized it as "misleading,*' the final response 
from EPA to Chairman Moss was virtually unchanged from the draft. 

CONCLUSION 

One EPA official described EPA's behavior by commenting that 
'''the stuff that's been written on the way reregistration is done was 
carefully worded to skirt the issue of thorough review." The record is 
more than adequate to support that characterization. And, even if 
unintentional, as EPA claims, EPA's statements regarding the re- 
registration program were clearly misleading. 



VI. RECOMMENDATIONS 

1. Thorough and expert review of all safety testing data on pesticides 
should be done for each compound prior to registering, reregistering, or 
granting tolerances. This is a fairly self-evident recommendation but 
EPA has simply not performed the reviews. Two quite elementary 
steps must be taken immediately. First, EPA must organize its own 
data files and in some cases find missing data files. Second, it must 
require its reviewers to read the files, including the correspondence 
files that contain the comments of prior reviewers. The embarrassing 
fact is that EPA in many cases cannot even find the material it is 
charged with assessing, and it has systematically failed to even read 
relevant material it possessed. 

2. In connection with the first recommendation, the safety testing 
data underlying previously granted residue tolerances should expedi- 
tiously be subject to the same thorough scientific review as the data 
used for reregistration. In addition, the EPA should immediately 
expedite the development and finalization of regulatory procedures for 
setting tolerances, and those procedures should fully reflect the find- 
ings of this report. 

3. The data submitted by manufacturers should be made public as a 
matter of course. The material to be withheld from public scrutiny 
should be narrowly defined, consistent with statutory definitions of 
confidential material, and the burden of identifying with particularity 
material claimed to be confidential should be imposed on the manu- 
facturers as a condition to EPA accepting data submissions. Timely 
public access to safety testing data has the potential for subjecting that 
data to additional scientific scrutiny by public interest groups, other 
Government agencies, independent scientists with an academic or 
other interest in a particular compound, and perhaps on occasion by the 
scientific personnel of competing pesticide companies. In any case, 
scrutiny of the data over and above what EPA can provide will sharpen 
the analyses and improve the regulatory effort. It might also provide 
some incentive for the companies to develop more accurate data and 
the EPA to improve the quality of its own internal reviews. 

4. In connection with ensuring that it will have a better data base, 
the EPA should expeditiously establish and implement an effective 
program to evaluate the testing procedures of and accuracy of data 
developed by laboratories utilized by pesticide manufacturers sub- 
mitting data to EPA. There have been serious problems experienced by 
the FDA in this regard and, since pesticide companies use some of the 
same labs used by drug companies, there is every reason to urge 
EPA to investigate and closely monitor the labs that develop pesticide 
safety data. 

In this connection, EPA should start vigorously investigating 
whether the pesticide manufacturers are disclosing all relevant safety 
data to EPA in a timely fashion. The performance of the Velsicol 

(49) 



50 

Chemical Corporation in its production of Leptophos, to cite just one 
example, clearly indicates that the agency is not receiving critically 
important information on the health effects of some pesticides. 

The problem of the falsification and withholding of safety data is one 
that is best addressed (A) through continual and systematic monitoring 
of the pesticide companies and the laboratories, and (B) swift and effec- 
tive sanctions for violations, including criminal prosecution for inten- 
tional violations in this area. Currently, EPA has neither committed 
the resources nor mustered the will to police these problems. 

5. Scientific talent should be utilized in a more effective manner. 
EPA should consider the possibility of developing a health-risk office, 
peopled by the best available scientific talent, and independent of any 
particular regulatory program — whether it be pesticides, toxic sub- 
stances or pure water. The health-risk office Would be charged with 
reviewing safety testing data developed from other sources, most 
notably pesticide manufacturers, and would have some capability to 
develop data on its own. Its mission would be to use its scientists to 
ferret out and assess health and environmental risks. They would not 
be required to assess benefits. 

6. Qualified scientific and management personnel should occupy the 
appropriate positions in the pesticide program. This is, of course, easier 
said than done. Although the agency must share part of the blame for 
unqualified personnel, a large part of the problem is the inability to 
attract first-class scientists because of inadequate financial induce- 
ments and civil service rules. The built-in impediments to such a 
recruiting program are not primarity the fault of EPA, but the EPA 
and other agencies facing similar problems should develop a plan to 
attract top-flight scientific talent and present that plan to the Congress 
for action. The Congress itself should be receptive to changes in civil 
service rules and Government pay ceilings that are carefully drawn to 
alleviate demonstrable shortcomings in the Government's ability to 
attract and keep the best scientists. 

o 



UNIVERSITY OF FLORIDA 
|| I llll Ill lllll 



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